FDANovember 19, 2014device
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
What to do
FDA enforcement status: Terminated
Brands named
ortho clinical diagnosticsorthoortho clinical
Recall history
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