cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
FDA Recall Z-0752-2021 · Posted None
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Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2020-11-23
Date Terminated2023-07-06
Product Quantity152 kits and 7 units
Reason for Recall
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).
Firm Action
On 11/20/2020, Roche issued Urgent Medical Device Correction notices to customers via phone and fax. Customers were advised to do the following:
A Roche Customer Support Center representative will contact the four affected customers by phone and a copy of UMDC TP-01155 will be faxed to the customer. Any customer questions or concerns will be addressed during the phone call.
Root Cause
Device Design
Distribution Pattern
Domestic: IL, FL, GA, WV
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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