Reported Aug 14, 2024 · Ongoing
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI)…
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 FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.
- Lot codes and dates
- Part NumberRFIT-ASY-0116 (30
- test kit) UDI-DI code00815381020109 0081538102011: All unexpired products are potentially impacted if used in conjunction with the Remel
- Cary Blair transport medium Part NumberRFIT-ASY-0104 (6
- test kit) UDI-DI code0081538102011 All unexpired products are potentially impacted if used in conjunction with the Remel Cary Blair transport medium Remel
- Cary-Blair Transport Medium lot numbers743930 769240 712258 782425 732357 742049
- Amount recalled
- 67,613 kits (or 2,028,309 pouches). Each pouch is used for each individual test.
Where it was sold
Why it was recalled
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
This product could cause temporary or reversible health problems — stop using it.
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