Becton Dickinson & Co. Recall 93789
Description: Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
Becton Dickinson & Co. Recall 93789 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1011-2024 |
| Event ID | 93789 |
| Event Description | Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing |
| 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. 231628 UDI-DI 00382902316282 Lots 2090490 2146520 2210201 2276143 3062095; Catalog No. 231629¿¿ UDI-DI 30382902316290 Lots 3163306 3163307 3163310 3254307 3254309 3271840 3271853 2146520 2146526 2147225 2210201 2224295 2276143 2276144 3003894 3062095 3090649 |
| Center Classification Date | 20240208 |
| Recall Initiation Date | 20240108 |
| Recalling Firm | Becton Dickinson & Co. |
| Initial Notification | Letter |
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