WhichRecall
Class IIReported 2026-01-14

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.

Recalled by Roche Diagnostics Operations, Inc.

Reason for Recall

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability

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Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

Recall Number
Z-1009-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-21
Reported
2026-01-14
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.
Code Info
08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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