BioFire Respiratory Panel 2 — Class II medical device recall Z-0602-2026
Ongoing recall by BioFire Diagnostics, LLC, reported 2025-12-03, distributed in AZ, FL, GA, ID, NC, NH, NJ, NY…. Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative
| Recall number | Z-0602-2026 |
|---|---|
| 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 | 2025-10-22 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Distributed | AZ, FL, GA, ID, NC, NH, NJ, NY, OR, PA, SC |
| UPC / GTIN / UDI-DI | 00815381020529 |
| Lot numbers | 1471725, 2649724 |
| Model numbers | 423742 |
Product
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Reason for recall
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
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-0602-2026. 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.