Internal reviews have confirmed two related problems with the Elecsys® Anti-TSHR assay. The test results for the same patient sample vary by instrument platforms (Cobas e 801/e 402 and Cobas e 411) or results vary by calibrator lot (only affecting Cobas e 411 platform). Roche will replace all of the impacted reagents still remaining in your inventory, free of charge. All newly manufactured lots are not impacted.
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