Saint Cloud, MN, United States
Microbiologics Inc recalls
41 recalls recorded since 2018, most recently on 2 December 2025. 14 are listed as ongoing. Status and classification are as published by the FDA.
Recalls41
Ongoing (FDA)14
Terminated or completed27
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 December 2025
- Reason
- Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Distribution
- Worldwide - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0984-2026, Z-0985-2026, Z-0986-2026
- KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
- KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
- LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Ongoing Class II Medical devices
- Recall started
- 13 November 2025
- Reason
- Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
- Distribution
- International distribution to the countries of UAE, China, Singapore, Kazakhstan,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0876-2026
- KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Ongoing Class II Medical devices
- Recall started
- 27 June 2025
- Reason
- KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
- Distribution
- Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Malaysia, Costa Rica.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2194-2025, Z-2195-2025
- LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
- LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
Ongoing Class II Medical devices
- Recall started
- 17 June 2025
- Reason
- Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
- Distribution
- US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2124-2025
- KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Ongoing Class II Medical devices
- Recall started
- 27 May 2025
- Reason
- Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
- Distribution
- US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1957-2025
- KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Ongoing Class II Medical devices
- Recall started
- 20 February 2025
- Reason
- The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
- Distribution
- US Nationwide distribution in the states of TX. UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1371-2025
- Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Ongoing Class II Medical devices
- Recall started
- 20 February 2025
- Reason
- The RSV target may give a late Ct value and could potentially not pass QC.
- Distribution
- Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1454-2025
- Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Ongoing Class II Medical devices
- Recall started
- 20 January 2025
- Reason
- Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1163-2025, Z-1164-2025
- Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
- Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Ongoing Class II Medical devices
- Recall started
- 6 March 2024
- Reason
- The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, MI, KY, MO, NM, TN, PR, and the countries of France, Columbia, Kazakhstan, Peru, Puerto Rico, South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1483-2024
- KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Ongoing Class II Medical devices
- Recall started
- 8 January 2024
- Reason
- The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NE, NH, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV, and WY. There was government distribution and no military distribution. Foreign distribution was made to France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1075-2024
- Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Ongoing Class II Medical devices
- Recall started
- 18 October 2023
- Reason
- A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0307-2024, Z-0308-2024
- KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
- LYFO-DISK, P. venetum, Catalog number 0794L
Ongoing Class III Medical devices
- Recall started
- 14 August 2023
- Reason
- One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
- Distribution
- US Nationwide distribution in the states of MN, PA, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2576-2023
- KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Terminated Class III Medical devices
- Recall started
- 27 July 2022
- Terminated
- 2 August 2024
- Reason
- Product not registered for use in the UK
- Distribution
- International distribution to the country of United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1740-2022
- Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Terminated Class III Medical devices
- Recall started
- 6 May 2022
- Terminated
- 16 January 2024
- Reason
- Labeling error.
- Distribution
- Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1125-2022
- KWIK-STIK" plus: Clostridium perfringens
Terminated Class II Medical devices
- Recall started
- 24 March 2022
- Terminated
- 9 January 2023
- Reason
- QC process was not adequate for the specification range.
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0954-2022
- Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Terminated Class II Medical devices
- Recall started
- 22 March 2022
- Terminated
- 9 January 2023
- Reason
- The QC process was not adequate for the specification range.
- Distribution
- US Nationwide distribution in the states of NV and VT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0955-2022
- Inactivated macrolide-resistant Mycoplasma genitalium
Terminated Class II Medical devices
- Recall started
- 3 March 2022
- Terminated
- 16 January 2024
- Reason
- Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
- Distribution
- US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0844-2022
- Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Terminated Class II Medical devices
- Recall started
- 25 February 2022
- Terminated
- 16 January 2024
- Reason
- Distributed product did not undergo proper release testing.
- Distribution
- Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0784-2022
- Mycoplasma genitalium Control Panel (Inactivated Pellet)
Terminated Class II Medical devices
- Recall started
- 20 August 2021
- Terminated
- 12 January 2023
- Reason
- The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2486-2021
- SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Terminated Class II Medical devices
- Recall started
- 20 August 2021
- Terminated
- 12 January 2023
- Reason
- The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2487-2021
- SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Terminated Class III Medical devices
- Recall started
- 24 February 2021
- Terminated
- 11 July 2022
- Reason
- Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
- Distribution
- US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0544-2022
- KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Terminated Class III Medical devices
- Recall started
- 24 February 2021
- Terminated
- 11 July 2022
- Reason
- Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
- Distribution
- Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0543-2022
- KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Terminated Class III Medical devices
- Recall started
- 16 December 2020
- Terminated
- 12 January 2023
- Reason
- The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0546-2022
- KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Terminated Class II Medical devices
- Recall started
- 16 December 2020
- Terminated
- 7 July 2022
- Reason
- Contamination with S. epidermidis
- Distribution
- Distribution was made to CA, IA, IL, LA, MA, MI, NY, PA, SD, TN, VA, WI, and WV. There was no government/military distribution. Foreign distribution was made to Brazil, Canada, Colombia, Dominican Republic, Finland, France, India, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Saudi Ar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0511-2022
- KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
Terminated Class II Medical devices
- Recall started
- 8 October 2020
- Terminated
- 3 November 2022
- Reason
- Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0402-2021
- Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for
Terminated Class II Medical devices
- Recall started
- 8 October 2020
- Terminated
- 17 November 2022
- Reason
- KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
- Distribution
- Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0303-2021, Z-0302-2021, Z-0304-2021
- Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moistur
- Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moistur
- Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moistur
Terminated Class III Medical devices
- Recall started
- 8 October 2020
- Terminated
- 7 July 2022
- Reason
- The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.
- Distribution
- US distribution to . International distribution to Austria, Botswana, Brazil, Canada, China, Colombia, Finland, France, Germany, Guatemala, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Malaysia, Mauritius, Netherlands, Norway, Oman, Peru, Poland, Romania
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0581-2022
- KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Terminated Class II Medical devices
- Recall started
- 1 October 2020
- Terminated
- 7 July 2022
- Reason
- Potential contamination with S. epidermidis E. coli and S. warneri.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0582-2022, Z-0584-2022, Z-0583-2022
- KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pelle
- QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swa
- LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to p
Terminated Class II Medical devices
- Recall started
- 18 February 2020
- Terminated
- 11 July 2022
- Reason
- Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
- Distribution
- Worldwide Distribution. US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0587-2022, Z-0589-2022, Z-0586-2022, Z-0588-2022, Z-0585-2022
- QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
- QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
- LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
- QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
- KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
Terminated Class II Medical devices
- Recall started
- 12 February 2020
- Terminated
- 26 March 2021
- Reason
- KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
- Distribution
- Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1691-2020, Z-1690-2020
- Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
- KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Terminated Class II Medical devices
- Recall started
- 3 January 2020
- Terminated
- 16 September 2020
- Reason
- Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.
- Distribution
- Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1096-2020
- Vaginal Verification Panel Ref 8208 Lot 8208-11
Terminated Class II Medical devices
- Recall started
- 16 December 2019
- Terminated
- 11 December 2020
- Reason
- The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.
- Distribution
- Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0812-2020
- Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may a
Ongoing Class III Medical devices
- Recall started
- 16 May 2019
- Reason
- Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
- Distribution
- NY, MN, NC, TX, GA, MO, PA, TN, NH, OH, CO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1838-2019
- Cepheid Xpert C. difficile/Epi Control Panel
Ongoing Class II Medical devices
- Recall started
- 9 April 2019
- Reason
- Product with incorrect shelf life.
- Distribution
- Worldwide Distribution - US Nationwide AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, MI, MO,MS, MT, NC, ND, NJ, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, and WY. Australia, Chile, Germany, New Zealand, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1730-2019, Z-1731-2019
- Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees reque
- Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees r
Terminated Class II Medical devices
- Recall started
- 31 January 2019
- Terminated
- 9 June 2020
- Reason
- Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Austria, Canada, Finland, Ireland, Malaysia, New Zealand, Portugal, South Africa, Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0982-2019
- Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Terminated Class II Medical devices
- Recall started
- 6 June 2017
- Terminated
- 17 January 2023
- Reason
- Real-time shelf life testing failed at 24 months
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0697-2022, Z-0700-2022, Z-0699-2022, Z-0698-2022, Z-0701-2022
- Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74,
- Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
- Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expirati
- Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
- Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
Terminated Class III Medical devices
- Recall started
- 2 March 2017
- Terminated
- 22 April 2022
- Reason
- Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
- Distribution
- International distribution in the countries of Canada and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0637-2022, Z-0636-2022
- LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to
- KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device
Terminated Class II Medical devices
- Recall started
- 1 December 2015
- Terminated
- 7 July 2022
- Reason
- The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, NC, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0704-2022, Z-0703-2022
- QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived
- QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derive
Completed Class III Medical devices
- Recall started
- 17 July 2015
- Reason
- LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
- Distribution
- Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0788-2022
Terminated Class II Medical devices
- Recall started
- 6 October 2014
- Terminated
- 17 January 2023
- Reason
- This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Nether
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0714-2022, Z-0712-2022, Z-0713-2022
- KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
- KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
- LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
Terminated Class III Medical devices
- Recall started
- 25 March 2013
- Terminated
- 22 April 2022
- Reason
- Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0641-2022
- KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
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.