Microbiologics Inc

12 FDA enforcement actions

12 Total Recalls

0 Class I

12 Class II

0 Class III

Firm Details

Product Types: device
States: MN

All Recalls

Class II: Risk 12/02/2025 device

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class II: Risk 12/02/2025 device

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class II: Risk 12/02/2025 device

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class II: Risk 11/13/2025 device

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Class II: Risk 06/27/2025 device

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: Risk 06/27/2025 device

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: Risk 06/17/2025 device

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: Risk 05/27/2025 device

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: Risk 02/20/2025 device

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Class II: Risk 02/20/2025 device

The RSV target may give a late Ct value and could potentially not pass QC.
Class II: Risk 01/20/2025 device

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: Risk 01/20/2025 device

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.