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Recall Observatory FDA recall evidence

Device product

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

Z-0752-2021

November 23, 2020

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 86897
Status
Terminated
Classification
Class II
Quantity
152 kits and 7 units
Official record key
device-enforcement:Z-0752-2021

Official wording

Reason: 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).

Code information: Catalog Number 08445605190 08445567190 08253153190 08058580190

Distribution pattern: Domestic: IL, FL, GA, WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).