Device product
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Z-1392-2023
Product summary
- Event
- Event 91892
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 900 pouches (30 kits)
- Official record key
device-enforcement:Z-1392-2023
Official wording
Reason: Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
Code information: Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109
Distribution pattern: US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.
Derived failure modes
-
Unknown
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.