medical Class II Updated 2021-01-06

Roche Diagnostics Operations, Inc. recalls Roche cobas pro integrated solutions (cobas pro ISE, cobas c

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10

View official government recall

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