Device evidence

device-recall:cfres:170767

BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.

Official recall number

Z-0981-2019

Evidence summary

Product code: PIC
Recall status: Terminated
Event initiated: January 14, 2019
Root cause: Nonconforming Material/Component
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-0981-2019