Reported Nov 7, 2018 · Terminated
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI:…
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 Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC
- Panel Catalog Numbers/ UDI
RFIT-ASY-0126 (30 test kit)/ 00815381020086RFIT-ASY-0127 (6 test kit)/ 00815381020093when used with
- the following blood culture bottlesBottle
- Description/Part Number
BACT/ALERT FA Plus/ 410851BACT/ALERT FN Plus/ 410852BACT/ALERT PF Plus/ 410853
- Lot codes and dates
- All lots.
- Amount recalled
- 18038
Where it was sold
- Nationwide
Why it was recalled
Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
This product could cause temporary or reversible health problems — stop using it.
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