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Recall Observatory FDA recall evidence

Device product

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.

Z-0652-2019

October 19, 2018

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 81563
Status
Terminated
Classification
Class II
Quantity
682
Official record key
device-enforcement:Z-0652-2019

Official wording

Reason: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

Code information: Product Code: 6802783 UDI 10758750002979 Product Code: 6802914 UDI 10758750007103 Serial Numbers: J36000109-J36001169

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software anomaly