Device product
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Z-1251-2023
Product summary
- Event
- Event 91647
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 kits
- Official record key
device-enforcement:Z-1251-2023
Official wording
Reason: Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Code information: Part Number: RFIT-ASY-0147 UDI: 0815381020338 Pouch Lot Number: 1766022
Distribution pattern: U.S. Nationwide distribution in the states of FL and GA.
Derived failure modes
-
Unknown
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.