Recall Z-2936-2026 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
BioFire Diagnostics, LLC
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
| Date | Aug 12, 2026 (initiated Jun 24, 2026) |
| Status | Open, Classified |
| Reason | Due to increase in false negative results |
| Root cause | Under Investigation by firm |
| Action | On 06/24/2026, an "URGENT MEDICAL DEVICE CORRECTION" Letter was emailed to customers informing them that bioMrieux received complaints of false-negative results associated with BIOFIRE RP2.1 kit lot 1872125 / pouch lot 3VLB25. An internal investigation confirmed the presence of incorrect PCR1 primers in a subset of pouches within BIOFIRE RP2.1 kit lot 1872125 introduced during reagent manufacturing. This field safety notice was issued because the incorrect PCR1 primers will lead to pouch pathogen assay negative results with passing control assays. Customers are instructed to: "Examine your in |
| Quantity | 2,370 pouches (79 kits) |
| Distribution | U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.