Roche Diagnostics Operations, Inc. cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
Catalog Number 08445605190 08445567190 08253153190 08058580190
Products Sold
Catalog Number 08445605190 08445567190 08253153190 08058580190
Roche Diagnostics Operations, Inc. is recalling cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinica due to During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvet. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, IL, WV
Page updated: Jan 10, 2026