Reported Apr 24, 2019 · Terminated
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the…
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, IVD, Rx Only, BioFire Diagnostics
- REF
RFIT-ASY-0126and RFIT-ASY-0127when 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
3 of 3 products · 28 lot codes
Recalled lot codes, grouped by product number Part Number Lot Numbers 4108514052663405263940526404052599405259840525474052546405247140524724052799405280040528154052816
4108524052871405287240524594052458405256540525644052705405270440527354052617405261
4108534052717405271840525034052504
- Amount recalled
- 20350
Where it was sold
Why it was recalled
Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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