Recall Z-1399-2024 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
BD Phoenix Yeast ID 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 | Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected. Esculin is expected to trigger this fluorescence and test cancellation. |
| 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 | 6700 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
This recall record lists no 510(k) number.