FDADecember 8, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

05641446001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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