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Ortho-Clinical Diagnostics recalls VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of
Recalled December 26, 2018 · FDA recall Z-0653-2019 · Ortho-Clinical Diagnostics
Hazard
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. · FDA Class II
Units
728
Sold at
US Nationwide Distribution
Description
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Product
VITROS 4600 Chemistry 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 →