Device evidence

device-recall:cfres:120037

bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

Official recall number

Z-1920-2013

Evidence summary

Product code: LTW
Recall status: Terminated
Event initiated: June 14, 2013
Root cause: Software change control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1920-2013