Device evidence

device-recall:cfres:166476

BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.

Official recall number

Z-0230-2019

Evidence summary

Product code: MDB
Recall status: Terminated
Event initiated: June 27, 2018
Root cause: Software design
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-0230-2019