Z-1251-2023 Class II Ongoing
FDA device recall Z-1251-2023 was initiated by BioFire Diagnostics, LLC on February 1, 2023 and is designated Class II. Reason for recall: 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 re… The recall status is ongoing. Affected quantity: 2 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2023
- Initiation Date
- February 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 kits
Product Description
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Reason for Recall
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.
Distribution Pattern
U.S. Nationwide distribution in the states of FL and GA.
Code Information
Part Number: RFIT-ASY-0147 UDI: 0815381020338 Pouch Lot Number: 1766022