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Roche Diagnostics Operations, Inc. recalls cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Recalled January 6, 2021 · FDA recall Z-0752-2021 · Roche Diagnostics Operations
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). · FDA Class II
Units
152 kits and 7 units
Sold at
Domestic: IL, FL, GA, WV
Description
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).
Product
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →