Des Plaines, IL, United States
Abbott Molecular, Inc. recalls
20 recalls recorded since 2018, most recently on 28 April 2025. 14 are listed as ongoing. Status and classification are as published by the FDA.
Recalls20
Ongoing (FDA)14
Terminated or completed6
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 28 April 2025
- Reason
- There were reports of an increase in reactive negative controls and false positive results.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1749-2025, Z-1748-2025
- Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA f
- Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation
Ongoing Class II Medical devices
- Recall started
- 20 March 2025
- Reason
- The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1665-2025
- The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).
Ongoing Class II Medical devices
- Recall started
- 12 September 2024
- Reason
- Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
- Distribution
- Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., EL SALVADOR
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0233-2025, Z-0234-2025
- Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
- Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
Ongoing Class II Medical devices
- Recall started
- 20 March 2024
- Reason
- The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
- Distribution
- Worldwide distribution - US Nationwide and the countries ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERM
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1602-2024
- Alinity m System, Part Number: 08N53-002
Ongoing Class III Medical devices
- Recall started
- 1 February 2024
- Reason
- Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
- Distribution
- US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1190-2024, Z-1188-2024, Z-1189-2024
- Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
- In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
- In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J
Ongoing Class II Medical devices
- Recall started
- 30 October 2023
- Reason
- Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0407-2024
- Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System
Ongoing Class II Medical devices
- Recall started
- 9 December 2022
- Reason
- The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
- Distribution
- x
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1009-2023
- Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.
Ongoing Class II Medical devices
- Recall started
- 22 November 2022
- Reason
- Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0739-2023, Z-0740-2023
- Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
- Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Ongoing Class II Medical devices
- Recall started
- 11 November 2022
- Reason
- The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
- Distribution
- US Distribution to state of: PA, a government account.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1349-2023
- Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Ongoing Class II Medical devices
- Recall started
- 12 October 2022
- Reason
- Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0268-2023
- Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Ongoing Class II Medical devices
- Recall started
- 19 August 2022
- Reason
- Reports received of an increase of message code 9186 (internal control failed) when using the kit.
- Distribution
- Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Chile and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1679-2022
- Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Completed Class II Medical devices
- Recall started
- 19 July 2022
- Reason
- Incorrect optical calibration
- Distribution
- There was only foreign distribution to Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1518-2022
- The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Ongoing Class II Medical devices
- Recall started
- 4 March 2022
- Reason
- There is a potential for misquantitation high results for negative samples.
- Distribution
- US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Por
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0884-2022, Z-0883-2022
- Alinity m HBV AMP Kit (US and CE)
- Alinity m HBV Application Specification File (US and CE)
Terminated Class II Medical devices
- Recall started
- 11 February 2022
- Terminated
- 14 April 2023
- Reason
- There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0710-2022
- Alinity m Integrated Reaction Units (IRU)
Ongoing Class II Medical devices
- Recall started
- 6 December 2021
- Reason
- There is a potential for abnormal (non-sigmoidal) amplification curves.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambiq
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0460-2022
- Alinity m System, Part No. 08N53-002
Ongoing Class II Medical devices
- Recall started
- 6 December 2021
- Reason
- There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambiq
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0461-2022
- Alinity m System, Part No. 08N53-002
Terminated Class II Medical devices
- Recall started
- 6 December 2021
- Terminated
- 14 August 2026
- Reason
- There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
- Distribution
- Worldwide distribution - US distribution and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozamb
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0462-2022
- Alinity m System, Part No. 08N53-002
Terminated Class II Medical devices
- Recall started
- 6 December 2021
- Terminated
- 30 September 2024
- Reason
- There is an issue with the installation of updated camera firmware on the system.
- Distribution
- Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0463-2022
- Alinity m System, Part No. 08N53-002
Terminated Class I Medical devices
- Recall started
- 2 September 2021
- Terminated
- 23 July 2024
- Reason
- There is a potential for false positive results.
- Distribution
- Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVE
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0007-2022, Z-0008-2022, Z-0004-2022, Z-0006-2022, Z-0005-2022
- Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
- Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
- Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
- Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
- Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Terminated Class II Medical devices
- Recall started
- 4 August 2021
- Terminated
- 31 May 2023
- Reason
- Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MI, MN, MA, NC, NJ, NM, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and the countries of Australia, Belgium, Brazil, Canada, China, Costa Rica, Czech Republic, Estonia, Germany, Hong Kong, Israel, Italy, Kaz
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2576-2021
- Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes
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.