Device product
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
Z-1038-2024
Product summary
- Event
- Event 93789
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,363,168 total units
- Official record key
device-enforcement:Z-1038-2024
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. 231541 UDI-DI 00382902315414 Lots 1278110 1334479 2004554 2025125 2056466 2242510 3214931; Catalog No. 231544¿ UDI-DI 30382902315446 Lots 1116055 1211489 2339407 3030278 3158059 3214931 0343413 1032232 1088790 1148547 1278110 1334479 2004554 2025125 2056466 2090443 2242510
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.