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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Roche Diagnostics Operations
- Product type
- Immunoassay
- Model numbers
- 08496633190 lot 840183 exp. 02/26, 08496633190 lot 874011 exp. 10/26, 08496609190 lot 840177 exp. 05/26
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 21, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the model numbers and lot numbers against the recall list.
- Verify the expiration dates of your immunoassay cassettes.
- 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.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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
- Class II recall
- Potential for misdiagnosis
- Nationwide distribution in the U.S.
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
