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.
Recall
- Recall Number
- Z-1009-2026
- Event Number
- 98103
- Firm
- Roche Diagnostics Operations, Inc.
- FEI Number
- 1823260
- Product Code
- JZO
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 21, 2025
- Posted
- January 2, 2026
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
Description
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.
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.
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.
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.
1300 cassettes