BioFire Blood Culture Identification 2 — Class II medical device recall Z-0312-2022
Terminated recall by BioFire Diagnostics, LLC, reported 2021-12-08, distributed nationwide. Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause m
| Recall number | Z-0312-2022 |
|---|---|
| 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 | 2021-10-11 |
| Classified | 2021-11-30 |
| Reported by FDA | 2021-12-08 |
| Terminated | 2023-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BH, CH, CL, CO, CR, CZ, DE, DZ, EC, EG, ES, FR, GB, GR, GT, HK, HR, HU, IL, IN, IT, KW, LV, MX, MY, NL, PA, PE, PH, PL, PT, PY, QA, RO, RS, SA, SE, SI, TH, TN, TR, UY, ZA |
| UPC / GTIN / UDI-DI | 00815381020338 |
| Model numbers | RFIT-ASY-0147 |
| Expiration dates | 2022-04-30 |
Product
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All lots with an expiry date prior to
Reason for recall
Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.
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-0312-2022. 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.