BioFire Diagnostics, LLC Recall 94942
Description: BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
BioFire Diagnostics, LLC Recall 94942 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2683-2024 |
| Event ID | 94942 |
| Event Description | BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia. |
| Quantity | 24 Kits |
| Recall Reason | Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer. |
| Device Classification | 20240828 |
| Device Code Info | UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024 |
| Center Classification Date | 20240816 |
| Recall Initiation Date | 20240610 |
| Recalling Firm | BioFire Diagnostics, LLC |
| Initial Notification | Letter |
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