Reported Aug 18, 2021 · Terminated
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126…
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)
- Panel Product Pouch LabelFilmArray
- BCID Panel Part NoRFIT-ASY-0126
- Part NoRFIT-ASY-0127
- Lot codes and dates
- Part NoRFIT-ASY-0126 /
- UDI00815381020086
- Part NoRFIT-ASY-0127 /
- UDI
00815381020093Kit Lot# 0868221Pouch Lot# 194Z21Batch 003
- Amount recalled
- 29 kits
Where it was sold
Why it was recalled
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
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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