Roche Diagnostics Operations, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0752-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

Product Classification:

Class II

Date Initiated: November 23, 2020

Date Posted: January 6, 2021

Recall Number: Z-0752-2021

Event ID: 86897

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).

Status: Terminated

Product Quantity: 152 kits and 7 units

Code Information:

Catalog Number 08445605190 08445567190 08253153190 08058580190

Distribution Pattern:

Domestic: IL, FL, GA, WV

Voluntary or Mandated:

Voluntary: Firm initiated