Elecsys Anti-TSHR Immunoassay Recalled for Diagnostic Test Result Variability
Roche is recalling 1,300 cassettes of the Elecsys Anti-TSHR immunoassay due to inconsistent test results across instrument platforms and lot-to-lot calibrator variability. These issues may cause delayed or incorrect diagnosis and treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall with no reported illnesses or injuries. The hazard involves diagnostic inaccuracy that could lead to delayed or incorrect diagnosis and improper treatment decisions. This meets the criterion for 'High' severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 1,300 cassettes of the Elecsys Anti-TSHR immunoassay, a diagnostic test that measures thyroid antibodies in patient serum samples using electrochemiluminescence detection.
The recall was initiated due to two identified problems: (1) test results vary depending on the instrument platform used to run the assay, and (2) calibrator solutions show lot-to-lot variability. These issues may lead to delayed or incorrect diagnosis, as well as delays or errors in treatment decisions.
The recalled products were distributed nationwide to healthcare facilities in 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, and West Virginia. The affected lot numbers are 840183 (code 08496633190, expiring 02/26), 874011 (code 08496633190, expiring 10/26), and 840177 (code 08496609190, expiring 05/26).
Healthcare facilities should verify their inventory for the affected lots and contact Roche Diagnostics Operations, Inc. for guidance on product return, replacement, or handling instructions.
The recalled product
- 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 immunocompl
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- diagnostic-error
- calibration-error
Distribution
Distributed nationwide across the United States.
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