Microbiologics Inc Recalls
14 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (14)
- Class II
December 2, 2025
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Class II
December 2, 2025
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Class II
December 2, 2025
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
- Class II
November 13, 2025
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
- Class II
June 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 failure to recover the target microorganism. All lots of REF 894-76 are impacted.
- Class II
June 27, 2025
LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
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.
- Class II
June 17, 2025
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
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.
- Class II
May 27, 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
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.
- Class II
February 20, 2025
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
- Class II
February 20, 2025
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
The RSV target may give a late Ct value and could potentially not pass QC.
- Class II
January 20, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
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.
- Class II
January 20, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
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.
- Class II
March 6, 2024
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
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.
- Class II
January 8, 2024
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
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.
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