Z-1944-2021 Class II Terminated
FDA device recall Z-1944-2021 was initiated by BioFire Diagnostics, LLC on April 16, 2021 and is designated Class II. Reason for recall: Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process. The recall status is terminated (terminated April 2, 2024). Affected quantity: 9 kits (U.S. only).
Recall Details
- Product Type
- Devices
- Report Date
- June 30, 2021
- Initiation Date
- April 16, 2021
- Termination Date
- April 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 kits (U.S. only)
Product Description
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Reason for Recall
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
Distribution Pattern
U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
Code Information
Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621