Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0752-2021 — cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

U.S. FDA — Device Enforcement · United States · 2020-11-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0752-2021
Date of alert
2020-11-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Operations, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08445605190
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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