Device product
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿
Z-1023-2024
Product summary
- Event
- Event 93789
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,363,168 total units
- Official record key
device-enforcement:Z-1023-2024
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. 231632¿ UDI-DI 00382902316329 Lots 2004587 2028883 2119589 2146527 2242568 2301371 3118111 3181037; Catalog No. 231633¿ UDI-DI 30382902316337 Lots 2242568 2301371 3062286 3118111 3181037 3223389 3290192 2004587 2028232 2028883 2028894 2056528 2119589 2146527
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.