Z-1392-2023 Class II Ongoing
FDA device recall Z-1392-2023 was initiated by BioFire Diagnostics, LLC on March 8, 2023 and is designated Class II. Reason for recall: Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. The recall status is ongoing. Affected quantity: 900 pouches (30 kits).
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- March 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900 pouches (30 kits)
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.
Distribution Pattern
US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.
Code Information
Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109