FDA recall record · openFDA

Microbiologics Inc

17 FDA recalls on record (2023–2025) — 17 device. 17 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. 3

Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This 2

KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All 2

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. 2

Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong micr 1

Recalls

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P Class II 2025-12-02 KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17 Class II 2025-05-27 Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic Class II 2025-01-20 Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagn Class II 2025-01-20 LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack) Class II 2025-06-27 KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K Class II 2025-11-13 Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control Class II 2025-02-20 Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed qu Class II 2025-02-20 KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K Class II 2025-12-02 LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L Class II 2025-12-02 LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L Class II 2025-06-27 KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L Class II 2025-06-17 Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. Class II 2024-01-08 KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for cultur Class II 2024-03-06 KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) Class II 2023-10-18 LYFO-DISK, P. venetum, Catalog number 0794L Class II 2023-10-18 KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing Class III 2023-08-14

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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