Microbiologics Inc
10 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.
- 2025-12-31FDA-DeviceClass IILYFO 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.
- 2025-12-31FDA-DeviceClass IIKWIK-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.
- 2025-12-31FDA-DeviceClass IIKWIK-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.
- 2025-12-10FDA-DeviceClass IIKWIK-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.
- 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.
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