Becton Dickinson & Co. Recall 86963
Description: BD Phoenix PMIC-107: 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: 448417
Becton Dickinson & Co. Recall 86963 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0761-2021 |
| Event ID | 86963 |
| Event Description | BD Phoenix PMIC-107: 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: 448417 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 103475 eaches |
| Recall 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 |
| Device Classification | 20210106 |
| Device Code Info | All unexpired lots UDI: 00382904484170 |
| Center Classification Date | 20201231 |
| Recall Initiation Date | 20201208 |
| Recalling Firm | Becton Dickinson & Co. |
| Initial Notification | Letter |
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