Recall Z-1398-2024 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with car
| Date | Mar 29, 2024 (initiated Feb 29, 2024) |
| Status | Open, Classified |
| Reason | Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results |
| Root cause | Under Investigation by firm |
| Action | BD issued URGENT: Medical Device Product Correction Product Removal letter on 2/29/24 via courier service via tracked letter and/or e-mail. Letter states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy affected product subject to the recall following your institution s process of destruction. 2. Ensure the contents of this notification are read and understood. 3. Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the |
| Quantity | 11,800 eaches |
| Distribution | Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132674 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) Becton, Dickinson and Company, Dec 27, 2013 |