FDA recall, , Moderate risk
Roche Diagnostics Elecsys Anti-TSHR Immunoassay
The Elecsys Anti-TSHR immunoassay results vary by instrument platform and calibrator lot, which may lead to delayed or incorrect diagnosis.
Summary by Recall Canary from the FDA notice
What happened
Roche Diagnostics Operations, Inc., of Indianapolis, Indiana, began recalling the Elecsys Anti-TSHR immunoassay on November 21, 2025. The agency identified two issues: results vary by instrument platform and calibrator lot-to-lot variability. These issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
The product is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. The recall affects 1300 cassettes distributed nationwide in 20 states and Puerto Rico. The FDA added the recall to its Enforcement Report on January 2, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
The Elecsys Anti-TSHR immunoassay
- UDI-DI
- 08496633190
- 08496609190
- Lot code
- 840183
- 874011
- 840177
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Illinois, Indiana, Maine, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, PR, Tennessee, Texas, Utah, Washington, West Virginia.
- Company
- Roche Diagnostics Operations, Inc.Indianapolis, Indiana
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98103
- Recall number
- Z-1009-2026
- Quantity recalled
- 1300 cassettes
All recalls from Roche Diagnostics Operations, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
