FDA Device recall Z-0570-2013
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Ph…
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Ph… by Becton Dickinson And, citing an antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0570-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-06 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
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
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Identifiers
| code_info | Lot number 2053373 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0570-2013%22
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