Reported Aug 7, 2024 · Ongoing
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in…
BioFire Diagnostics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioFire Diagnostics, LLC · 515 S Colorow Dr · Salt Lake City, UT · 84108-1248
Is this the product you have?
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel
- REFRFIT-ASY-0147, for FILMARRAY Systems, when used in
- conjunction with Culture Media BottlesBACT/ALERT FA PLUS
- REF410851, and BACT/ALERT PF PLUS
- REF410853
- Lot codes and dates
- BCID2 Panel REFRFIT-ASY-0147
- UDI-DI00815381020338, All unexpired lots
- BACT/ALERT REF/UDI-DILot/Expiration: 410851/03573026596057: 0004101638/3/20/2024, 0004101930/7/28/2024, 0004102026/9/4/2024, 0004102408/2/16/2025, 0004102996/9/24/2025, 0004102946/8/29/2025, 0004102956/9/17/2025, 0004102998/9/24/2025. 410853/03573026596095: 0004101718/4/24/2024, 0004101790/6/1/2024, 0004101958/8/3/2024, 0004102452/3/3/2025, 0004102964/9/19/2025
- Amount recalled
- 99,822
Where it was sold
Why it was recalled
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
This product could cause temporary or reversible health problems — stop using it.
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