FilmArray Pneumonia Panel — Class II medical device recall Z-1944-2021
Terminated recall by BioFire Diagnostics, LLC, reported 2021-06-30, distributed nationwide. Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to i
| Recall number | Z-1944-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioFire Diagnostics, LLC, Salt Lake City, UT, United States |
| Recall initiated | 2021-04-16 |
| Classified | 2021-06-24 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2024-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 9 kits |
| UPC / GTIN / UDI-DI | 00815381020178 |
| Lot numbers | 0938121, 19T621 |
| Model numbers | RFIT-ASY-0144 |
Product
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Reason for recall
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
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-1944-2021. 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.