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Recall Observatory FDA recall evidence

Device product

BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceptibility testing.

Z-1013-2024

January 08, 2024

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 93789
Status
Ongoing
Classification
Class II
Quantity
2,363,168 total units
Official record key
device-enforcement:Z-1013-2024

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. 231660¿ UDI-DI 30382902316603 Lots 3010074 3093387 3163062 3223403 3234193 2063349 2119619 2276123

Distribution pattern: Domestic distribution nationwide. International distribution worldwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.