medical Class II Updated 2024-02-14

Becton Dickinson & Co. recalls BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitati

Recalled Product

BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿


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. 232174 UDI-DI 00382902321743 Lots 1301766 1341479 2119610 2147329 2242618 2276113 2333166 3152004 3181140; Catalog No. 232175¿ UDI-DI 30382902321751 Lots 1301766 2276113 2333166 2333175 3152004 3181140 1341479 2119610 2119612 2147329 2242618
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