FDA Device recall Z-3246-2024
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically signific…
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically signific… by Becton Dickinson And, citing 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 tr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3246-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-01 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Phoenix M50 instrument -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: 443624
Reason
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,
Identifiers
| code_info | UDI: 00382904436247 All serial numbers that have prior Phoenix M50 System Software Version 2.85.0.0 and PUD V7.41A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3246-2024%22
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