Device product
BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
Z-1026-2024
Product summary
- Event
- Event 93789
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,363,168 total units
- Official record key
device-enforcement:Z-1026-2024
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. 230733¿¿ UDI-DI 00382902307334 Lots 1020750 1116997 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 2277205 3003821 3129527 3263117 9336993 0080290 0178844 0258758; Catalog No. 231274¿ UDI-DI 30382902312742 Lots 2277205 3003821 3129527 3263117 0057245 0080290 1057453 1116997 1148461 1180198 1211448 1277739 1301482 1334126 2025900 2063283 2210054 9336993
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.