FDA Medical devices recall ·
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay… recall
- Recall number
- Z-1009-2026
- Date
- (initiated November 21, 2025)
- Company / brand
- Roche Diagnostics Operations, Inc.
9115 Hague Rd, Indianapolis, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1300 cassettes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26
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.
States: Arizona California Florida Georgia Illinois Indiana Maine Michigan Minnesota North Carolina New Jersey New Mexico New York Ohio Pennsylvania Puerto Rico Tennessee Texas Utah Washington West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1009-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.