Ortho-Clinical Diagnostics recalls VITROS 5,1 FS Chemistry System, Version 3.0 & below For
Recalled Product
VITROS 5,1 FS Chemistry System, Version 3.0 & 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.
Hazard / Issue
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Issued by
FDA
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