BioFire Diagnostics, LLC Recall 87936
Description: FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
BioFire Diagnostics, LLC Recall 87936 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1944-2021 |
| Event ID | 87936 |
| Event Description | FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None |
| Quantity | 9 kits (U.S. only) |
| Recall Reason | Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process. |
| Device Classification | 20210630 |
| Device Code Info | Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621 |
| Center Classification Date | 20210624 |
| Recall Initiation Date | 20210416 |
| Recalling Firm | BioFire Diagnostics, LLC |
| Initial Notification | Letter |
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