Recall Z-1025-2024 ยท JTN Susceptibility Test Discs, Antimicrobial
Becton Dickinson & Co.
BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621
| Date | Feb 8, 2024 (initiated Jan 8, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On January 8, 2024, the firm notified customers through URGENT Medical Device Product Correction letters. Users were instructed to cease use of catalog number 291270, and to refrain from conducting AST for H. influenzae with impacted Sensi-Discs. Customers should destroy any units of catalog number 291270 in their inventory. Customers should share and post the recall notification within their facility network and forward to any customers to whom they may have distributed the product. Future lots of affected Sensi-Disc products (excluding catalog number 291270) will be labeled with a sticke |
| Quantity | 2,363,168 total units |
| Distribution | Domestic distribution nationwide. International distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K832515 | CEFUROXIME 30 MCG SENSI-DISC Bd Becton Dickinson Vacutainer Systems Preanalytic, Oct 14, 1983 |