Roche Diagnostics Operations, Inc. recalls cobas pro integrated solutions -cobas c 503, Analyzer, chemi
Recalled Product
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Hazard / Issue
During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).
Issued by
FDA
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