Device product
BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
Z-1028-2024
Product summary
- Event
- Event 93789
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,363,168 total units
- Official record key
device-enforcement:Z-1028-2024
Official wording
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.
Code information: Catalog No. 231678¿ UDI-DI 30382902316788 Lots 1305187 2119623 2339435 3129541
Distribution pattern: Domestic distribution nationwide. International distribution worldwide.
Derived failure modes
-
Unknown
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.