Recall Z-0232-2023 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
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
| Date | Nov 14, 2022 (initiated Oct 13, 2022) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | BD initiated the recall on October 13, 2022 via Urgent Medical Device Product Advisory states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above and ensure the contents of this Product Advisory are read and understood. 2. It is recommended to suspend reporting of Minocyline AST results to clinicians for the affected lot. 3. Share and post this Product Advisory letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4. Complete the |
| Quantity | 13,900 EA |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070809 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML Becton, Dickinson & CO, Sep 24, 2007 |