BioFire Diagnostics, LLC Recall 93526
Description: The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.
BioFire Diagnostics, LLC Recall 93526 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0704-2024 |
| Event ID | 93526 |
| Event Description | The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems. |
| Product Type | Devices |
| Distribution | US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD |
| Quantity | 57 Kits |
| Recall Reason | A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission. |
| Device Classification | 20240117 |
| Device Code Info | UDI-DI: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024 |
| Center Classification Date | 20240110 |
| Recall Initiation Date | 20231127 |
| Recalling Firm | BioFire Diagnostics, LLC |
| Initial Notification | Letter |
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