Roche Diagnostics Operations, Inc. recalls

2 recalls.

• cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample... recall (Roche Diagnostics Operations, Inc.)
  Medical deviceClass IIReported March 11, 2026 · Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an...
• The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with... recall (Roche Diagnostics Operations, Inc.)
  Medical deviceClass IIReported January 14, 2026 · Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as...