FDAJune 17, 2025device
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
microbiologics
UPCs
3084535701953110845357019544
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K2025-12-02
- 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-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
- FDAHelix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N2025-02-20
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