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U.S. Department of Health and Human Services

Class 2 Device Recall Cobas pro integrated solutions cobas c 503

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 Class 2 Device Recall Cobas pro integrated solutions cobas c 503see related information
Date Initiated by FirmNovember 23, 2020
Create DateDecember 29, 2020
Recall Status1 Terminated 3 on July 06, 2023
Recall NumberZ-0752-2021
Recall Event ID 86897
510(K)NumberK191899 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Productcobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Code Information Catalog Number 08445605190 08445567190 08253153190 08058580190
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactRoche Customer Support Center
317-521-4343
Manufacturer 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).
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce152 kits and 7 units
DistributionDomestic: IL, FL, GA, WV
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJE
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