Roche Diagnostics Operations Recalls

2 recalls found for Roche Diagnostics Operations. Check if any of your products are affected.

HIGHFDA DEVICE

Jan 20, 2026

Roche Cobas Pro 1,261-Unit Recall Over Spline-Calibration Error (2026)

Roche Diagnostics issued a nationwide recall of 1,261 Cobas Pro systems with cobas c 503 units in the United States. A software defect can cause erroneous, non-monotonic calibrations for spline-type assays. Labs should stop using the devices immediately and follow the manufacturer's recall instructions.

Roche Diagnostics Operations

Software defect,

HIGHFDA DEVICE

Nov 21, 2025

Roche Diagnostics Recalling Anti-TSHR Immunoassay Over Diagnosis Risk

Roche Diagnostics Operations recalled 1,300 Anti-TSHR immunoassay cassettes on November 21, 2025. Variability in results may lead to incorrect diagnoses and treatment delays. The recall affects multiple states across the U.S.

Roche Diagnostics Operations

Issues identified:

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