FDA Device recall Z-1031-2024
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing by Becton Dickinson And, citing 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 resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1031-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-08 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
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.
Identifiers
| code_info | Catalog No. 231644 UDI-DI 00382902316442 Lots 1335006 2056580 2091918 2210318 2301385 3062101 3094134 3118125 3214950;…Catalog No. 231644 UDI-DI 00382902316442 Lots 1335006 2056580 2091918 2210318 2301385 3062101 3094134 3118125 3214950; Catalog No. 231645¿ UDI-DI 30382902316450 Lots 3062101 3094134 3118125 3214950 3261103 1335006 2056580 2081151 2091918 2091925 2147704 2210318 2210343 2277500 2301385 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1031-2024%22
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