FDAJanuary 20, 2025device
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
microbiologics
UPCs
70845357043077
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAKWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K2025-12-02
- FDALYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L2025-12-02
- FDAKWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P2025-12-02
- FDAKWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K2025-11-13
- FDALYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)2025-06-27
- FDALYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L2025-06-27
- FDAKWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L2025-06-17
- FDAKWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 124932025-05-27
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