Reported May 2, 2018 · Terminated
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and…
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?
- FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
- Lot codes and dates
- All lot numbers are involved
- UDI00815381020086 (RFIT-ASY-0126), 00815381020093 (RFIT-ASY-0127). The expiration dates of the BD BACTEC Blood Culture Bottles are 9/30/2018 and beyond
- Amount recalled
- N/A
Where it was sold
- Nationwide
- GA
Why it was recalled
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
This product could cause temporary or reversible health problems — stop using it.
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