Device evidence

device-recall:cfres:115795

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.

Official recall number

Z-0976-2013

Evidence summary

Product code: NJR
Recall status: Terminated
Event initiated: December 11, 2012
Root cause: Process control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0976-2013