Device product
BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231644 and 231645¿
Z-1031-2024
Product summary
- Event
- Event 93789
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,363,168 total units
- Official record key
device-enforcement:Z-1031-2024
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. 231644 UDI-DI 00382902316442 Lots 1335006 2056580 2091918 2210318 2301385 3062101 3094134 3118125 3214950; Catalog No. 231645¿ UDI-DI 30382902316450 Lots 3062101 3094134 3118125 3214950 3261103 1335006 2056580 2081151 2091918 2091925 2147704 2210318 2210343 2277500 2301385
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.