FDA Device recall Z-1027-2024
BD BBL Sensi Disc Ciprofloxacin- 5 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 Ciprofloxacin- 5 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-1027-2024 |
| 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 Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
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. 231657¿ UDI-DI 00382902316572 Lots 1060926 1279842 2028533 2091948 2301402 3214964 3248370; Catalog No. 23…Catalog No. 231657¿ UDI-DI 00382902316572 Lots 1060926 1279842 2028533 2091948 2301402 3214964 3248370; Catalog No. 231658¿ UDI-DI 30382902316580 Lots 1335458 2336475 3062295 3093427 3163048 3214964 3248370 0344330 1007112 1060926 1127037 1279842 1335457 2028533 2028547 2091948 2091980 2301402 2336474 |
|---|
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-1027-2024%22
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