BIOFIRE Blood Culture Identification 2 — Class II medical device recall Z-0451-2024
Ongoing recall by BioFire Diagnostics, LLC, reported 2023-12-13, distributed nationwide. Routine quality control testing of affected blood culture identification panel with affected control panel may
| Recall number | Z-0451-2024 |
|---|---|
| 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 | 2023-10-17 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, ES, FI, FR, GB, GR, GT, HN, HR, HU, ID, IE, IL, IN, IS, JO, JP, KR, KW, LB, LT, LV, MA, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SV, TH, TN, TR, TW, UY, VE, VN, ZA |
| Quantity | 32,910 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00815381020338 |
| Model numbers | RFIT-ASY-0147 |
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251
Reason for recall
Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive 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-0451-2024. 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.