FDA Device recall Z-0232-2023
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative a…
- FDA Device
- Class II
- ongoing
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class II recall of BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative a… by Becton Dickinson And, citing misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0232-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-13 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology System. Catalog (Ref) Number: 448607
Reason
Misformulated minocycline-can cause erroneously increased Minimal Inhibitory Concentration (MIC) values when performing antibiotic susceptibility testing (AST) against minocycline and result in the reporting of false resistance for clinical samples if the initial Quality Control (QC) testing of the panel batch passes, delaying treatment of the patient with the most appropriate antibiotic
Identifiers
| code_info | UDI: (10) 1355046 (17) 230131 (30) 0025 (01) 30382904486076 Lot Number: 1355046 Exp. Date: 31JAN2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0232-2023%22
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