Roche Diagnostics Operations, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0755-2021)

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:

Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001

Product Classification:

Class II

Date Initiated: December 8, 2020

Date Posted: January 6, 2021

Recall Number: Z-0755-2021

Event ID: 86981

Reason for Recall:

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

Status: Ongoing

Product Quantity: 7 units

Code Information:

Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated