medical Class II Updated 2024-02-14

Becton Dickinson & Co. recalls BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantit

Recalled Product

BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.


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. 231640¿ UDI-DI 00382902316404 Lots 1117192 1211613 1243750 1278287 3214945; Catalog No. ¿231641 UDI-DI 30382902316412 Lots 2304491 3093375 3184116 3214945 3261101 3282901 1117192 1211613 1278287 1305148 2004458 2028924 2090502 2244457
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