CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report

The Elecsys Anti-TSHR immunoassay is a three-step recalled

Roche Diagnostics Operations is recalling The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with, distributed nationwide in the US. The recall was initiated on 21 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26

Quantity recalled1300 cassettes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1009-2026
FDA event ID: 98103
Recalling firm: Roche Diagnostics Operations, Indianapolis, IN
Classification: Class II
Status: Ongoing
Recall initiated: 21 Nov 2025
FDA classified: 2 Jan 2026
Reported: 14 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Test Kits & Diagnostics

Timeline

21 Nov 2025	Recall initiated by company
2 Jan 2026	Classified by FDA	+42 days
14 Jan 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide 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

Questions about this recall

Why was it recalled?

Which lots are affected?

08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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