Thyroid receptor immunoassay recalled over variable results across instrument platforms
Roche Diagnostics is recalling 1,300 Elecsys Anti-TSHR cassettes because results vary by instrument platform and calibrator lots vary, which may lead to incorrect diagnosis or 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: Scored 3 under the risk-of-harm criterion: the firm states the issues may lead to incorrect diagnosis or incorrect treatment, and no injuries are reported.
Plain-English summary
The Elecsys Anti-TSHR immunoassay, described in the record as a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection, is being recalled by Roche Diagnostics Operations, Inc.
Two issues were identified: results vary by instrument platform, and calibrator lot-to-lot variability. The firm states these issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
The record lists 1,300 cassettes, covering 08496633190 lot 840183 expiring 02/26, 08496633190 lot 874011 expiring 10/26 and 08496609190 lot 840177 expiring 05/26. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should follow Roche's 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.
- Category
- Medical Device — Immunoassay
- Hazard
- result-variability
- calibrator-variability
- misdiagnosis-risk
Distribution
Distributed nationwide across the United States.
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