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.
This recall is currently active, issued January 2, 2026. It was issued by Roche Diagnostics Operations, Inc..
- Recall Initiated
- November 21, 2025
- Posted
- January 2, 2026
- Recall Number
- Z-1009-2026
- Quantity
- 1300 cassettes
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26
Root Cause
Process control
Action Taken
Firm notified customers on November 21, 2025 via Urgent Medical Device Correction notices. Customers using the cobas e 402/801 and cobas e411 were instructed to immediately discontinue using the impacted lots outlined in the UMDC and switch to the new unaffected lot numbers listed in the communication.