Class II — Becton Dickinson & Co.
| Recalling firm | Becton Dickinson and Company |
|---|---|
| Registered facility | View this company's 36 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645® |
| Quantity | 2,363,168 total units |
| Distribution | Domestic distribution nationwide. International distribution worldwide. |
| Initiated | 2024-01-08 |
| Classified | 2024-02-08 |
| Recall number | Z-1031-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Becton Dickinson & Co. (Z-1031-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93789/
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