Microbiologics Inc

Complete recall history across all FDA and CPSC categories — 66 total recalls

Microbiologics Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (66)

FDA medical device enforcement actions by Microbiologics Inc. Showing most recent 50.

Date Product Reason Class
Dec 2, 2025 LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalo... Affected units may fail to recover the target microorganism Campylobacter jej... Class II
Dec 2, 2025 KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... Affected units may fail to recover the target microorganism Campylobacter jej... Class II
Dec 2, 2025 KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428,... Affected units may fail to recover the target microorganism Campylobacter jej... Class II
Nov 13, 2025 KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus der... Some products packaged for lot 818-111-7 may have been packaged in pouches la... Class II
Jun 27, 2025 LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failu... Class II
Jun 27, 2025 LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pa... KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failu... Class II
Jun 17, 2025 KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 080... Affected products contain Staphylococcus epidermidis instead of the expected ... Class II
May 27, 2025 KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K... Affected products were packaged with the incorrect KWIK STIK assembly resulti... Class II
Feb 20, 2025 Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory S... The RSV target may give a late Ct value and could potentially not pass QC. Class II
Feb 20, 2025 Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet... The A549 human cell target (human cells for sample adequacy control) may give... Class II
Jan 20, 2025 Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (In... Internal quality control procedures were not followed correctly for the testi... Class II
Jan 20, 2025 Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactiv... Internal quality control procedures were not followed correctly for the testi... Class II
Mar 6, 2024 KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b... The positive control material (Rhizopus stolonifer) within the KWIK-STIK asse... Class II
Jan 8, 2024 Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. The negative control was contaminated with one of the positive control pathog... Class II
Oct 18, 2023 LYFO-DISK, P. venetum, Catalog number 0794L A complaint investigation showed that the bulk pellets (lot 794-142) were con... Class II
Oct 18, 2023 KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) A complaint investigation showed that the bulk pellets (lot 794-142) were con... Class II
Aug 14, 2023 KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 60... Class III
Jul 27, 2022 Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... Product not registered for use in the UK Class III
May 6, 2022 KWIK-STIK" plus: Clostridium perfringens Labeling error. Class III
Mar 24, 2022 Inactivated macrolide and quinolone-resistant Mycoplasma genitalium QC process was not adequate for the specification range. Class II
Mar 22, 2022 Inactivated macrolide-resistant Mycoplasma genitalium The QC process was not adequate for the specification range. Class II
Mar 3, 2022 Pneumonia (33 Targets) Control Panel, unassayed quality control material, con... Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be... Class II
Feb 25, 2022 Mycoplasma genitalium Control Panel (Inactivated Pellet) Distributed product did not undergo proper release testing. Class II
Aug 20, 2021 SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an ext... The product indicated is contaminated with a plasmid DNA that contains the ta... Class II
Aug 20, 2021 SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an e... The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include... Class II
Feb 24, 2021 KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged... Potential that products packaged for lot 726-57-10 were packaged in pouches l... Class III
Feb 24, 2021 KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0... Potential of products packaged for lot 323-108-7 were packaged in pouches lab... Class III
Dec 16, 2020 KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO ... Contamination with S. epidermidis Class II
Dec 16, 2020 KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affecte... The expiration date on the label of one component (negative control 0243U) in... Class III
Oct 8, 2020 Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-... Class II
Oct 8, 2020 Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 0114... Class II
Oct 8, 2020 KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is... Class III
Oct 8, 2020 Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule o... KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 0114... Class II
Oct 8, 2020 Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage... Strain should be VIM-1 positive but is confirmed to be VIM-1 negative. Class II
Oct 1, 2020 LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49... Potential contamination with Escherichia coli, Staphylococcus epidermidis an... Class II
Oct 1, 2020 QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Co... Potential contamination with Escherichia coli Staphylococcus epidermidis and ... Class II
Oct 1, 2020 KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packa... Potential contamination with S. epidermidis E. coli and S. warneri. Class II
Feb 18, 2020 KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2... Tests returning incorrect susceptible results. High Level Gentamicin Synergy... Class II
Feb 18, 2020 QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that ... Tests returning incorrect susceptible results. High Level Gentamicin Synergy... Class II
Feb 18, 2020 LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic ... Tests returning incorrect susceptible results. High Level Gentamicin Synergy... Class II
Feb 18, 2020 QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verificatio... Tests returning incorrect susceptible results. High Level Gentamicin Synergy... Class II
Feb 18, 2020 QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that ... Tests returning incorrect susceptible results. High Level Gentamicin Synergy... Class II
Feb 12, 2020 KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 077... KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive... Class II
Feb 12, 2020 Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, conta... KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive... Class II
Jan 3, 2020 Vaginal Verification Panel Ref 8208 Lot 8208-11 Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant C... Class II
Dec 16, 2019 Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel ... The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Cont... Class II
May 16, 2019 Cepheid Xpert C. difficile/Epi Control Panel Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. Class III
Apr 9, 2019 Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 7084535704... Product with incorrect shelf life. Class II
Apr 9, 2019 Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226... Product with incorrect shelf life. Class II
Jan 31, 2019 Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expira... Class II

View all 66 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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