FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Reported: April 26, 2023 Initiated: March 8, 2023 #Z-1392-2023
Product Description
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Reason for Recall
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 900 pouches (30 kits)
- Distribution
- US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit). Recalled by BioFire Diagnostics, LLC. Units affected: 900 pouches (30 kits).
Why was this product recalled? ▼
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2023. Severity: Moderate. Recall number: Z-1392-2023.
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