Home / Recalls / Medical Devices
Becton Dickinson & Co. recalls BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences C
Recalled April 3, 2013 · FDA recall Z-0976-2013 · Becton Dickinson &
Hazard
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. · FDA Class II
Units
27 boxes/648 cartridges
Sold at
Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium
Description
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
Product
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.
Manufacturer(s)
Becton Dickinson & Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →