medical Class II Updated 2024-02-14

Becton Dickinson & Co. recalls BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quanti

Recalled Product

BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog No. 231250 UDI-DI 00382902312505 Lots 1085656 1277053 1301694 1334451 2025108 2119580 2146396 3181025; Catalog No. 231251¿ UDI-DI 30382902312513 Lots 1007140 2146396 3181025 3234149 1085656 1210753 1277053 1301694 1334451 2025108 2119580
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