Skip to main content

Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: 2 recalls listed since January 2026 across FDA.

By year

  • 20262

By agency

  • FDA2

By category

  • Medical Device2

All recalls (2)

Cobas Pro Integrated Solutions with Cobas C 503 analytical Units

The cobas pro integrated solutions with cobas c 503 analytical units have a software defect that can cause erroneous patient results.

Moderate risk, FDA, , Software defect

Roche Diagnostics Elecsys Anti-TSHR Immunoassay

The Elecsys Anti-TSHR immunoassay results vary by instrument platform and calibrator lot, which may lead to delayed or incorrect diagnosis.

Moderate risk, FDA, , Device defect
Embed this list