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.
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 delay of treatment or incorrect treatment.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Roche Diagnostics Operations, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall involves the Elecsys Anti-TSHR immunoassay with model numbers 08496633190 lot 840183 exp. 02/26, 08496633190 lot 874011 exp. 10/26, and 08496609190 lot 840177 exp. 05/26. The product was distributed nationwide in states including California, Texas, and Florida.
The immunoassay has shown variability in results depending on the instrument platform used. This can lead to delayed or incorrect diagnoses, affecting patient treatment.
No specific injury or incident counts have been reported at this time, but the potential for misdiagnosis poses a significant health risk.
Patients and healthcare providers must stop using the affected immunoassay cassettes immediately. Contact Roche Diagnostics Operations for further instructions and follow the recall instructions provided.
For further assistance, contact Roche Diagnostics Operations, Inc. Visit their website or call the provided support number for specific guidance.
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