HIGH

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.

Quick Facts at a Glance

Recall Date
November 21, 2025
Hazard Level
HIGH
Brand
Roche Diagnostics Operations
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

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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About This Product

The Elecsys Anti-TSHR immunoassay is a diagnostic test used to measure antibodies related to thyroid function. Healthcare providers utilize this test to aid in diagnosing thyroid disorders.

Why This Is Dangerous

Variability in test results based on the instrument platform used can lead to misinterpretation of patient health. This may result in delayed or incorrect treatment for thyroid-related conditions.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may experience delays in diagnosis and treatment, leading to potential worsening of thyroid disorders if the test results are inaccurate.

Practical Guidance

How to identify if yours is affected

  1. Check the model numbers and lot numbers against the recall list.
  2. Verify the expiration dates of your immunoassay cassettes.
  3. Contact your healthcare provider for assistance in identifying affected products.

Where to find product info

Serial numbers and lot numbers are typically printed on the product packaging or the product itself.

What timeline to expect

Expect processing for refunds to take 4-6 weeks after the return is received by Roche Diagnostics.

If the manufacturer is unresponsive

  • Document all correspondence with Roche Diagnostics.
  • Follow up via phone or email if you do not receive a timely response.
  • Consider reporting unresolved issues to the FDA.

How to prevent similar issues

  • Always verify that medical devices have current certifications and reviews.
  • Look for recent warnings or recalls on medical devices before purchase.
  • Consult healthcare providers for recommendations on reliable diagnostic tests.

Documentation advice

Keep records of your purchase, correspondence regarding the recall, and any medical advice received.

Product Details

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.

Key Facts

  • 1,300 units recalled
  • Class II recall
  • Potential for misdiagnosis
  • Nationwide distribution in the U.S.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
08496633190 lot 840183 exp. 02/26
08496633190 lot 874011 exp. 10/26
08496609190 lot 840177 exp. 05/26
Affected States
ALL
Report Date
January 14, 2026
Recall Status
ACTIVE

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