Device evidence

device-recall:cfres:168971

VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.

Official recall number

Z-0652-2019

Evidence summary

Product code: JJE
Recall status: Terminated
Event initiated: October 19, 2018
Root cause: Software Manufacturing/Software Deployment
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-0652-2019