Home / Recalls / Medical Devices
Ortho-Clinical Diagnostics recalls VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a va
Recalled December 26, 2018 · FDA recall Z-0652-2019 · Ortho-Clinical Diagnostics
Hazard
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. · FDA Class II
Units
682
Sold at
US Nationwide Distribution
Description
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
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.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →