Recall Z-1009-2026 ยท JZO System, Test, Thyroid Autoantibody
Roche Diagnostics Operations, Inc.
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.
| Date | Jan 2, 2026 (initiated Nov 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1300 cassettes |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193313 | Elecsys Anti-TSHR Roche Diagnostics, Feb 27, 2020 |