Recall Z-0704-2024 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
BioFire Diagnostics, LLC
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.
| Date | Jan 10, 2024 (initiated Nov 27, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On 11/27/23, recall notices were emailed to laboratory directors who were asked to do the following: Discontinue use and discard any remaining pouches that are subject to this recall. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. Complete and return the acknowledgement form using the following URL: https://www.biofiredx.com/recall5797 Customers with questions can contact Technical Support at biofire |
| Quantity | 57 Kits |
| Distribution | US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.