Becton Dickinson & Co. Recall 93789
Description: BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
Becton Dickinson & Co. Recall 93789 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1038-2024 |
| Event ID | 93789 |
| Event Description | BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿ |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. International distribution worldwide. |
| Quantity | 2,363,168 total units |
| Recall Reason | There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process. |
| Device Classification | 20240214 |
| Device Code Info | Catalog No. 231541 UDI-DI 00382902315414 Lots 1278110 1334479 2004554 2025125 2056466 2242510 3214931; Catalog No. 231544¿ UDI-DI 30382902315446 Lots 1116055 1211489 2339407 3030278 3158059 3214931 0343413 1032232 1088790 1148547 1278110 1334479 2004554 2025125 2056466 2090443 2242510 |
| Center Classification Date | 20240208 |
| Recall Initiation Date | 20240108 |
| Recalling Firm | Becton Dickinson & Co. |
| Initial Notification | Letter |
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