BD Phoenix 100-Intended for the rapid identification — Class II medical device recall Z-3247-2024
Ongoing recall by Becton Dickinson & Co., reported 2024-10-02, distributed nationwide. Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrume
| Recall number | Z-3247-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2024-08-01 |
| Classified | 2024-09-24 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DO, DZ, EC, EG, ES, FR, GB, GH, GR, GT, HK, HN, HR, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, KY, LB, LK, LT, LU, MA, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SG, SV, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 764 |
| Reason classes | microbial contamination |
| Pathogens | e coli |
| UPC / GTIN / UDI-DI | 00382904481001 |
| Model numbers | 448100 |
Product
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
Reason for recall
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
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-3247-2024. 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.