Roche recalls Elecsys Anti-TSHR immunoassay kits due to inconsistent results across instruments and calibrator variations, which may lead to delayed or incorrect thyroid treatment. Affected lots: 08496633190 (exp 02/26), 08496633190 (exp 10/26), 08496609190 (exp 05/26).
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.
“Roche Elecsys Anti-TSHR Assay Recall: Inconsistent Results Risk Incorrect Diagnosis.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50633-roche-elecsys-anti-tshr-assay-recall-inconsistent-results-risk-incorrect. Based on FDA recall #Z-1009-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1009-2026%22&limit=1).
Roche Diagnostics Operations, Inc. recalled The Elecsys Anti-TSHR immunoassay due to potential calibration variability that may lead to delayed or incorrect diagnosis and treatment, the FDA said on Nov. 21, 2025.
How to tell if you have it
Brand: Roche
Product: The Elecsys Anti-TSHR immunoassay
Lot/Expiration: 08496633190 lot 840183 exp. 02/26
Lot/Expiration: 08496633190 lot 874011 exp. 10/26
Lot/Expiration: 08496609190 lot 840177 exp. 05/26
Quantity: 1300 cassettes
The hazard
The recall addresses issues where results vary by instrument platform and calibrator lot-to-lot variability, which may lead to delayed or incorrect diagnosis as well as delay of treatment or incorrect treatment.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 2, 2019. Other recent recalls include the Roche cobas pro integrated solutions recall (Jan. 20, 2026) and the Roche cobas HCYS Assay Recall (Oct. 17, 2024). Similar recent recalls of similar products include the Immunotech Estrone RIA Kit Recall (Dec. 15, 2025), the GET TESTED Thyroid TSH Test Recall (Nov. 3, 2025), and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).
How to tell if you have this one
Check the lot numbers on the kit packaging: 08496633190 (expires 02/26), 08496633190 (expires 10/26), or 08496609190 (expires 05/26). These kits were sold with specific expiration dates.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Numbers
Look for lot numbers 08496633190 (exp 02/26), 08496633190 (exp 10/26), or 08496609190 (exp 05/26) on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 20 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, ME, MI, MN, NC, NJ, NM, NY, OH, PA, PR, TN, TX, UT, WA, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Georgia, Illinois, Indiana, Maine, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Washington, West Virginia.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1009-2026 (November 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1009-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.