FDA-Device2026-01-14Class IIPROCESSING DEFECT
Roche Elecsys Anti-TSHR immunoassay recalled for inconsistent test results
OTHERNationwide distribution
Contact your lab if you used Roche Elecsys Anti-TSHR
Roche Diagnostics has recalled certain lots of the Elecsys Anti-TSHR blood test due to inconsistent results across different laboratory instruments and variations between calibrator batches. These issues could lead to incorrect or delayed thyroid diagnosis and treatment.
- If your doctor ordered an Anti-TSHR (thyroid receptor antibody) test, contact your lab or healthcare provider to confirm which test kit was used
- Ask if your results came from one of the recalled lot numbers (840183, 874011, or 840177)
- If your lab used a recalled lot, discuss whether your test results should be repeated with a different kit
Hazard
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.
Sold states
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.
Affected count
1300 cassettes
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2026Don't want to check this manually?
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