Z-0752-2021 Class II Terminated
FDA device recall Z-0752-2021 was initiated by Roche Diagnostics Operations, Inc. on November 23, 2020 and is designated Class II. 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 af… The recall status is terminated (terminated July 6, 2023). Affected quantity: 152 kits and 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 6, 2021
- Initiation Date
- November 23, 2020
- Termination Date
- July 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 152 kits and 7 units
Product Description
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
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 Pattern
Domestic: IL, FL, GA, WV
Code Information
Catalog Number 08445605190 08445567190 08253153190 08058580190