BioFire Respiratory Panel 2 — Class II medical device recall Z-1877-2025
Ongoing recall by BioFire Diagnostics, LLC, reported 2025-06-04. Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative re
| Recall number | Z-1877-2025 |
|---|---|
| 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 | 2025-04-30 |
| Classified | 2025-05-29 |
| Reported by FDA | 2025-06-04 |
| Countries outside the US | SG |
| Quantity | 30 kits |
| Lot numbers | 1475424 |
| Model numbers | 423740 |
Product
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Reason for recall
Due to manufacturing error, respiratory panel may result in elevated control failures and/or 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-1877-2025. 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.