BIOFIRE Blood Culture Identification 2 — Class II medical device recall Z-2456-2024
Ongoing recall by BioFire Diagnostics, LLC, reported 2024-08-07, distributed nationwide. If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then
| Recall number | Z-2456-2024 |
|---|---|
| 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 | 2024-06-19 |
| Classified | 2024-07-31 |
| Reported by FDA | 2024-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 99,822 |
| UPC / GTIN / UDI-DI | 00815381020338, 03573026596057, 03573026596095 |
| Lot numbers | 0004101638, 0004101718, 0004101790, 0004101930, 0004101958, 0004102026, 0004102408, 0004102452, 0004102946, 0004102956, 0004102964, 0004102996, 0004102998, 410851/03573026596057, 410853/03573026596095 |
| Model numbers | 410851, 410853, RFIT-ASY-0147 |
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
Reason for recall
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
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-2456-2024. 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.