Class IIOngoingZ-0986-2026
Microbiologics Inc recalls LYFO DISK
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Microbiologics IncMNDec 31, 2025
Microbiologics Inc recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 12 recalls
Class IIOngoingZ-0985-2026
Microbiologics Inc recalls KWIK-STIK 6-Pack
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Microbiologics IncMNDec 31, 2025
Class IIOngoingZ-0984-2026
Microbiologics Inc recalls KWIK-STIK 2-Pack
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Microbiologics IncMNDec 31, 2025
Class IIOngoingZ-0876-2026
Microbiologics Inc recalls KWIK-STIK
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Microbiologics IncMNDec 10, 2025
Class IIOngoingZ-2195-2025
Microbiologics Inc recalls LYFO-DISK
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.
Microbiologics IncMNAug 6, 2025
Class IIOngoingZ-2194-2025
Microbiologics Inc recalls LYFO-DISK
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.
Microbiologics IncMNAug 6, 2025
Class IIOngoingZ-2124-2025
Microbiologics Inc recalls KWIK-STIK and LYFO DISK
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.
Microbiologics IncMNJul 23, 2025
Class IIOngoingZ-1957-2025
Microbiologics Inc recalls KWIK-STICK
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.…
Microbiologics IncMNJun 18, 2025
Class IIOngoingZ-1454-2025
Microbiologics Inc recalls Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial V…
The RSV target may give a late Ct value and could potentially not pass QC.
Microbiologics IncMNApr 2, 2025
Class IIOngoingZ-1371-2025
Microbiologics Inc recalls Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet)
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Microbiologics IncMNMar 26, 2025
Class IIOngoingZ-1164-2025
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated…
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.…
Microbiologics IncMNFeb 19, 2025
Class IIOngoingZ-1163-2025
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
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.…
Microbiologics IncMNFeb 19, 2025