Abbott Park, IL, United States
Abbott Laboratories recalls
41 recalls recorded since 2018, most recently on 13 November 2025. 18 are listed as ongoing. Status and classification are as published by the FDA.
Recalls41
Ongoing (FDA)18
Terminated or completed23
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 13 November 2025
- Reason
- Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
- Distribution
- Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR; and OUS (foreign) to countries of: Al
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0961-2026
- Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Ongoing Class II Medical devices
- Recall started
- 18 September 2025
- Reason
- Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
- Distribution
- Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0489-2026
- Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component:
Ongoing Class II Medical devices
- Recall started
- 18 March 2025
- Reason
- When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
- Distribution
- Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armen
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1652-2025, Z-1654-2025, Z-1655-2025, Z-1656-2025, Z-1653-2025
- Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
- Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
- Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
- Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
- Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Ongoing Class II Medical devices
- Recall started
- 14 June 2024
- Reason
- 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, OK, NC and the countries of ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, Botswana, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2681-2024
- Alinity hq Analyzer, REF: 09P68-01
Ongoing Class II Medical devices
- Recall started
- 21 February 2024
- Reason
- The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IL, KS, LA, MI, MO, MS, NE, NY, OH, OR, PA, TX, VA, and WI. The countries of Angola, Austria, Belarus, Belgium, Brazil, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1476-2024
- ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Terminated Class II Food
- Recall started
- 31 October 2023
- Terminated
- 3 September 2024
- Reason
- Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
- Distribution
- Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York,
- Initiated
- Voluntary: Firm initiated
- Recall number
- F-0328-2024
- Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Ongoing Class II Medical devices
- Recall started
- 19 October 2023
- Reason
- The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
- Distribution
- Distribution was made to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Brazil.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0604-2024
- Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
Ongoing Class II Medical devices
- Recall started
- 19 October 2023
- Reason
- The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV O.U.S.: Brazil
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0680-2024, Z-0681-2024, Z-0682-2024
- Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using ch
- Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using pho
- ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potent
Ongoing Class II Medical devices
- Recall started
- 30 May 2023
- Reason
- There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
- Distribution
- US: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BERMUDA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0613-2024
- Alinity ci-series System Control Module, REF: 03R70-01
Terminated Class II Food
- Recall started
- 28 March 2023
- Terminated
- 14 December 2023
- Reason
- Potential of foreign material (hard plastic) within product
- Distribution
- AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- F-0698-2023
- Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
Ongoing Class III Medical devices
- Recall started
- 24 November 2022
- Reason
- Reaction vessels may contain a potential contaminant that could affect their optical performance.
- Distribution
- US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0958-2023
- Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Terminated Class II Food
- Recall started
- 13 October 2022
- Terminated
- 14 August 2024
- Reason
- Compromised seal integrity which could lead to spoilage
- Distribution
- Domestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Ham
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-0156-2023, F-0160-2023, F-0158-2023, F-0157-2023, F-0161-2023, F-0159-2023, F-0165-2023, F-0162-2023, F-0164-2023, F-0155-2023, F-0154-2023, F-0163-2023
- Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
- Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
- Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
- Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
- Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
- Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
- Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
- Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 26 July 2022
- Reason
- One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1660-2022
- ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Terminated Class II Food
- Recall started
- 3 July 2022
- Terminated
- 9 June 2023
- Reason
- Potential leaking/pinholes in bottle
- Distribution
- Distributed to consignees in MD, NY, AL, FL, MA, NJ, and MI
- Initiated
- Voluntary: Firm initiated
- Recall number
- F-1575-2022
- Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL OZ (1L) Bottles 270 FL OZ (8L) Liter UPC: 7007462681 62681
Ongoing Class II Medical devices
- Recall started
- 9 June 2022
- Reason
- There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
- Distribution
- US: AK AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND NE NJ NV NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: ALBANIA ALGERIA ANDORRA ANGOLA ARGENTINA ARMENIA AUSTRALIA AUSTRIA AZERBAIJAN BAHAMAS BANGLADESH BELARUS BELGIUM BERMUDA BOSNIA AND HERZEGOVI BRAZIL BRUNEI BULGA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1456-2022, Z-1454-2022, Z-1455-2022
- REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
- REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
- REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Terminated Class III Food
- Recall started
- 3 June 2022
- Terminated
- 21 December 2022
- Reason
- The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.
- Distribution
- AZ, CA, FL, GA, IL, IN, MN, NC, NY, OH, KS, and TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- F-1312-2022
- Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ (17g) PACKETS/NET WT. 3.6 OZ (102g)***INGREDIENTS: ANHYDROUSE DEXTROSE, CITRIC ACID
Terminated Class II Food
- Recall started
- 3 June 2022
- Terminated
- 14 April 2023
- Reason
- These products are being recalled due to the potential of leakage from the 1L container.
- Distribution
- AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MI, MO, MS, NC, NH, NY, OH, OR, PA, TN, TX, UT, VA and WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-1343-2022, F-1344-2022
- Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L***INGREDIENTS: WATER, DEXTROSE*** Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-
- Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L*** INGREDIENTS: WATER, DEXTROSE***Abbott Nutrition, Abbott Laboratories, Columbus, Ohio
Ongoing Class II Medical devices
- Recall started
- 8 March 2022
- Reason
- This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
- Distribution
- Worldwide Distribution: US (nationwide) and OUS (foreign) including countries of: AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVI, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, IRAQ, ITALY, KAZAKHSTAN, LITHUANIA, LUXEMBOURG, MACEDONIA, MOROCCO, PANAMA, PORTUGAL, QATAR, ROMANIA, SAUDI ARA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0891-2022
- ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of
Ongoing Class I Food
- Recall started
- 17 February 2022
- Reason
- Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced
- Distribution
- US Nationwide. Worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-0935-2022, F-0936-2022, F-0922-2022, F-0932-2022, F-0923-2022, F-0919-2022, F-0941-2022, F-0945-2022, F-0937-2022, F-0938-2022, F-0956-2022, F-0925-2022 and 29 more
- Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac Pro-Advance 34oz. plastic jar. 6 jars per case. Item numbers: 53359 6808
- Abbott Alimentum, Abbott Similac Alimentum, Abbott Similac Alimentum HMO, Abbott Alimentum Similac, Abbott Similac Gold Alimentum HMO 400g can. 6 cans per case. Item numbers: 674845 6748406 6748408 6748412 6748
- Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per case. Item numbers: 63013 Retail UPCs: 070074629506 70074629506
- Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail UPCs: 055325002567 055325002581
- Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 Retail UPCs: 070074537306
- Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 54598 5459813 5459814 5459820 5459886 6771009 Retail UPCs: 70074545998 0700
- Abbott Similac For Spit Up Infant Formula with Iron 7oz. can and 19.5oz. plastic jar. 6 units per case. Item numbers: 67927 68086 Retail UPCs: 070074679280 070074680873
- Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Organic with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. 23.2oz plastic jar. 6 jars per case. Item numbers: 68013 6809
- and 33 more product lines
Ongoing Class II Medical devices
- Recall started
- 3 February 2022
- Reason
- Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
- Distribution
- Worldwide distribution: US (nationwide) including states of: AL, CA, GA, IL, IN, MN, MO, NC, OK, PA, RI, SC, TN, TX, WA, WI, MD and countries (OUS) including of: Australia, Austria, Bahrain, Belgium, Brazil, china, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0749-2022
- Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immuno
Ongoing Class II Medical devices
- Recall started
- 29 September 2021
- Reason
- Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: AFGHANISTAN ALBANIA, ALGERIA, ANDORRA, ANGOLA, ARGENTINA, ARMENIA, AUSTR
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0271-2022, Z-0272-2022
- ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
- ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
Ongoing Class II Medical devices
- Recall started
- 26 July 2021
- Reason
- Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico; Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2472-2021
- Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Ongoing Class II Medical devices
- Recall started
- 12 July 2021
- Reason
- A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
- Distribution
- Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2276-2021
- Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories
Ongoing Class II Medical devices
- Recall started
- 10 June 2021
- Reason
- There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of VA, UT, TX, TN, SD,PA, NY, ME, ID, CA and the countries of AFGHANISTAN, AUSTRALIA, AUSTRIA, BAHAMAS, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVI, CANADA, CAYMAN ISLANDS, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FAROE ISLAND, FINLAND,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2187-2021, Z-2184-2021, Z-2186-2021, Z-2185-2021
- REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
- REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569
- REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
- REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Terminated Class II Medical devices
- Recall started
- 2 April 2020
- Terminated
- 28 April 2021
- Reason
- In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of NC, ND, SC, TN. The countries of United Kingdom, France, New Zealand, Pakistan, Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2251-2020
- Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows con
Terminated Class III Medical devices
- Recall started
- 1 April 2020
- Terminated
- 1 September 2020
- Reason
- Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
- Distribution
- International distributed only in Mexico, no US distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1894-2020, Z-1893-2020, Z-1895-2020
- ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
- ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
- ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Terminated Class II Food
- Recall started
- 13 September 2019
- Terminated
- 30 April 2020
- Reason
- Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.
- Distribution
- Nationwide in the US. Canada and Malaysia.
- Initiated
- FDA Mandated
- Recall number
- F-0022-2020
- Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
Terminated Class III Medical devices
- Recall started
- 24 May 2019
- Terminated
- 1 April 2021
- Reason
- Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed worldwide to ALGERIA, ANDORRA, AUSTRI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2078-2019, Z-2079-2019
- ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human E
- ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and in
Terminated Class II Medical devices
- Recall started
- 22 May 2019
- Terminated
- 22 January 2021
- Reason
- Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, FKL GA, IA, ID, IL, IN, KS, LA, MN, MO, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, and WI; and countries of Austria, Germany, Italy, South Africa, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1688-2020
- "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
Terminated Class II Medical devices
- Recall started
- 9 May 2019
- Terminated
- 7 October 2020
- Reason
- The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
- Distribution
- Distribution was made to GA, LA, MA, NC, NY, SC, and TX. There was no military/government distribution. Foreign distribution was made to Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0173-2020
- Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
Terminated Class II Medical devices
- Recall started
- 1 May 2019
- Terminated
- 2 July 2021
- Reason
- Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.
- Distribution
- Worldwide distribution US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, ME, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and St. Croix US Virgin Islands. Countries of A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1671-2020
- ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is u
Terminated Class III Medical devices
- Recall started
- 9 April 2019
- Terminated
- 20 December 2019
- Reason
- Devices were delivered without the required dry ice.
- Distribution
- Distribution to Latvia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1358-2019, Z-1360-2019, Z-1361-2019, Z-1363-2019, Z-1359-2019, Z-1362-2019, Z-1356-2019, Z-1355-2019, Z-1357-2019
- ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma
- ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations
- ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase aut
- Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in
- ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of t
- Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in
- ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole
- ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 20 February 2019
- Terminated
- 13 August 2021
- Reason
- There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Co
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1074-2019
- CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
Terminated Class II Medical devices
- Recall started
- 2 January 2019
- Terminated
- 30 June 2021
- Reason
- Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias specification and demonstrate depressed recovery of up to 37%. The specific cause of the negative bias/depressed results is currently under investigation.
- Distribution
- Worldwide Distribution: US (nationwide) and to countries of: CHINA, THAILAND, GUATEMALA, and EL SALVADOR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0971-2019
- ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
Terminated Class II Medical devices
- Recall started
- 7 September 2018
- Terminated
- 2 February 2021
- Reason
- The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.
- Distribution
- US: TX, VA, AZ, NV, MA, LA, MN, PA, SC, NJ, NY, CA, IL, IN, WA, FL, TN, PA, KS, ND, NC, CT OUS: Argentina, Australia, Belgium, Canada, China, Denmark, France, Greece, Hong Kong, Ireland, Italy, New Zealand, Norway, Oman, Pakistan, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Spain, Tai
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2755-2019
- APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Terminated Class II Medical devices
- Recall started
- 28 August 2018
- Terminated
- 23 September 2020
- Reason
- There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS, NJ, NY, PA, SC, TX, VT, WA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Australia, China, Hong Kong, and New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1296-2019
- Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or ur
Terminated Class II Medical devices
- Recall started
- 18 July 2018
- Terminated
- 13 August 2020
- Reason
- The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
- Distribution
- Distribution was made nationwide, including Puerto Rico. There was also government and military distribution. Foreign distribution was made to Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1076-2019, Z-1075-2019
- Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
- Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Terminated Class II Medical devices
- Recall started
- 17 July 2018
- Terminated
- 23 September 2020
- Reason
- There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
- Distribution
- Worldwide distribution - US Nationwide and countries Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina FASO, Canada, Cayman Islands, Chile, China, Colomb
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1102-2019, Z-1104-2019, Z-1103-2019
- Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform
- Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform
- Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform
Terminated Class II Medical devices
- Recall started
- 14 June 2018
- Terminated
- 8 September 2021
- Reason
- Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.
- Distribution
- US, Canada, Netherlands, Germany, Great Britain, France, Ireland, Belgium
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2522-2018
- CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
Terminated Class II Medical devices
- Recall started
- 16 May 2018
- Terminated
- 16 August 2021
- Reason
- An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Distribution
- Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, B
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1992-2019, Z-1990-2019, Z-1991-2019, Z-1988-2019, Z-1989-2019, Z-1994-2019, Z-1995-2019, Z-1987-2019, Z-1993-2019
- C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex c
- Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune c
- Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form in
- Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune c
- Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune c
- Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insol
- Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex.
- C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an inc
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 8 December 2017
- Terminated
- 11 July 2019
- Reason
- There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Cayman
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0922-2018, Z-0921-2018, Z-0923-2018
- ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction
- ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction c
- ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.