Roche Diagnostics Operations, Inc. is recalling approximately 1,300 cassettes of the Elecsys Anti-TSHR immunoassay, a laboratory test used to detect thyroid stimulating hormone receptor antibodies. The recall was initiated because results may vary depending on the instrument platform used, and there is inconsistent performance between different calibrator lots. These issues could cause laboratories to report incorrect patient data, potentially leading to errors in medical diagnosis and treatment.
Inconsistent or incorrect test results can lead to a delayed or incorrect diagnosis of thyroid-related conditions, which may result in a delay of treatment or the administration of improper medical care.
Quantity: 1,300 cassettes. Used on various instrument platforms.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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