Microbiologics Inc
13 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Microbiologics Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-08-06FDA-DeviceClass IILYFO-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.
- 2025-08-06FDA-DeviceClass IILYFO-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.
- 2025-07-23FDA-DeviceClass IIKWIK-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.
- 2025-06-18FDA-DeviceClass IIKWIK-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.
- 2025-04-02FDA-DeviceClass IIHelix 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.
- 2025-03-26FDA-DeviceClass IIHelix 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.
- 2025-02-19FDA-DeviceClass IIMicrobiologics 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.
- 2025-02-19FDA-DeviceClass IIMicrobiologics 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.
- 2024-04-17FDA-DeviceClass IIKWIK-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.
- 2024-02-21FDA-DeviceClass IIMicrobiologics 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.
- 2023-11-22FDA-DeviceClass IILYFO-DISK, P. venetum, Catalog number 0794L
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
- 2023-11-22FDA-DeviceClass IIKWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
- 2023-09-20FDA-DeviceClass IIIKWIK-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, 6018P Parabacteroides distasonis.
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