Health Canada — Medical Devices · Canada · 2013-07-23 · Type III
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Reported risk: Siemens Healthcare Diagnostics is informing customers that a rare variant of TSH, identified in a small cluster of patients, is not detected by the siemens assays. As part of an investigation of unexplained discordant results, samples were identified in which the monoclonal antibody used in the reagent failed to detect the TSH molecule. These individuals may have a previously unrecognized, functionally normal TSH variant. The observed rate of occurrence during a 30-month time period was 0.6 x 10-7.
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