Recall Z-0766-2021 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 449036:
| Date | Dec 8, 2020 |
| Status | Terminated |
| Reason | BD Phoenix Sulfamethoxazole-trimethoprim (SXT) Resistance, false resistant SXT result with S. aureus could lead to a potential loss of access to a preferred antibiotic regimen and potential reduction in effectiveness of treatment of the infection |
| Root cause | Nonconforming Material/Component |
| Action | BD issued letters Urgent Medical Device Correction mailed beginning December 8, 2020 with FedEx tracking. Letter states reason for recall, health risk and action to take: 1.Share this product correction notification with all BD Phoenix" users within your facility network and post a copy near all BD Phoenix" instruments until the revised User Manual is available. 2. Respond to the product correction notification electronically by using the link BD.com/IDS-21-3976 or by returning to the attached Customer Response Form to the BD contact noted on the form so that BD may acknowledge your receipt o |
| Quantity | 253575 eaches |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.