Becton Dickinson & Co. Recall 91010
Description: 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
Becton Dickinson & Co. Recall 91010 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0232-2023 |
| Event ID | 91010 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 13,900 EA |
| Recall 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 |
| Device Classification | 20221123 |
| Device Code Info | UDI: (10) 1355046 (17) 230131 (30) 0025 (01) 30382904486076 Lot Number: 1355046 Exp. Date: 31JAN2023 |
| Center Classification Date | 20221114 |
| Recall Initiation Date | 20221013 |
| Recalling Firm | Becton Dickinson & Co. |
| Initial Notification | Letter |
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