FDAJanuary 3, 2020device
Vaginal Verification Panel Ref 8208 Lot 8208-11
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.
What to do
FDA enforcement status: Terminated
Brands named
microbiologics
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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