cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
This recall has been terminated (originally issued November 23, 2020).
- Recall Initiated
- November 23, 2020
- Terminated
- July 6, 2023
- Recall Number
- Z-0752-2021
- Quantity
- 152 kits and 7 units
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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).
Distribution
Domestic: IL, FL, GA, WV
Lot / Code Info
Catalog Number 08445605190 08445567190 08253153190 08058580190
Root Cause
Device Design
Action Taken
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.