FDAAugust 20, 2021device
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).
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.
- 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 0894L2025-06-27
- FDALYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)2025-06-27
- 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
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →