FDA Device recall Z-1040-2024
BD BBL Sensi Disc Tetracycline 30 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 Tetracycline 30 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-1040-2024 |
| 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 Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
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. 230998 UDI-DI 00382902309987 Lots 1242880 1277918 1301570 2025088 2056233 2118569 2276681 3094187 3212760 3…Catalog No. 230998 UDI-DI 00382902309987 Lots 1242880 1277918 1301570 2025088 2056233 2118569 2276681 3094187 3212760 3263267 9009914 9046895 0065366 0178210; Catalog No. 231344¿ UDI-DI 30382902313442 Lots 3010027 3062263 3094187 3158029 3212760 3263267 3275644 0065366 0085202 0230453 0274792 0335906 1095603 1148539 1180271 1242880 1277918 1301570 2025088 2056233 2089874 2118569 2276681 8355562 9009914 9046895 9130797 9239639 9263061 |
|---|
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-1040-2024%22
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