BIOFIRE FILMARRAY Pneumonia Panel plus — Class II medical device recall Z-2683-2024
Ongoing recall by BioFire Diagnostics, LLC, reported 2024-08-28, distributed nationwide. Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, whic
| Recall number | Z-2683-2024 |
|---|---|
| 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 | 2024-06-10 |
| Classified | 2024-08-16 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, EC, ES, FR, GR, IL, JP, RO, RS, SG, TW |
| Quantity | 24 kits |
| UPC / GTIN / UDI-DI | 00815381020314 |
| Lot numbers | 2147723 |
| Model numbers | RFIT-ASY-0143 |
Product
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Reason for recall
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
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-2683-2024. 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.