BD Phoenix PMIC-108 Panels — Class II medical device recall Z-0570-2013
Terminated recall by Becton Dickinson & Co., reported 2012-12-26, distributed nationwide. An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinicall
| Recall number | Z-0570-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2012-11-06 |
| Classified | 2012-12-19 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-01-09 |
| Distributed | Nationwide (US) |
| Quantity | 12,250 tests |
| Reason classes | microbial contamination |
| Lot numbers | 2053373 |
| Model numbers | 448418 |
Product
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
Reason for recall
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
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-0570-2013. 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.