BIOFIRE Respiratory Panel 2 — Class II medical device recall Z-2936-2026
Ongoing recall by BioFire Diagnostics, LLC, reported 2026-08-19, distributed nationwide. Due to increase in false negative results
| Recall number | Z-2936-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2026-06-24 |
| Classified | 2026-08-12 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00815381020529 |
| Lot numbers | 1872125, 3VLB25 |
| Model numbers | 423742 |
Product
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Reason for recall
Due to increase in false negative results
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2936-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.