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FDANovember 23, 2020device

cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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).

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

08445605190084455671900825315319008058580190

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use — Recall Details · AllClear