Device 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.
Z-0976-2013
Product summary
- Event
- Event 64310
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 boxes/648 cartridges
- Official record key
device-enforcement:Z-0976-2013
Official wording
Reason: Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
Code information: Lot/Exp. date: 2235001 2014-08-22
Distribution pattern: Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium
Derived failure modes
-
Unknown
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.