Device product
In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
Z-1252-2023
Product summary
- Event
- Event 91647
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 kits
- Official record key
device-enforcement:Z-1252-2023
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: 423742 UDI: 00815381020482 Pouch Lot Number: 1551622
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.