Reported Dec 8, 2021 · Terminated
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog…
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 Part NoRFIT-ASY-0147
- UDI00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All lots with an expiry date prior to
- Lot codes and dates
- Blood Culture Identification 2 (BCID2)
- Panel Part NumberRFIT-ASY-0147
- UDI Code00815381020338 Blood Culture Media Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All BCID2 Panel lots BD Blood Culture Media vials with expiration date of April 30, 2022 or earlier
- Amount recalled
- Total 14,140 Kits [11,155 kits (U.S.) and 2,985 kits (O.U.S.)]
Where it was sold
Why it was recalled
Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.
This product could cause temporary or reversible health problems — stop using it.
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