Immulite and Immulite 2000 Anti-Tg AB Systems and Immulite 1000 System — recall 51565
Health Canada — Medical Devices · Canada · 2014-04-14 · Type III
As described by Health Canada — Medical Devices: Immulite and Immulite 2000 Anti-Tg AB Systems and Immulite 1000 System - Thyroid Autoantibody Assay (2014-03-24)
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Reported risk: Siemens Healthcare Diagnostics has confirmed that the Intra-Assay and Inter-Assay Precision of the Immulite/Immulite 1000 and Immulite/Immulite 2000 XPI Anti-TG AB assays does not align with the representative data published in the instructions for use (IFU). Siemens has conducted a "verification of precision performance" study to assess precision. While the concentrations did not exactly match those published in the IFU, the study provides verification that the current precision performance is not in line with the IFU.
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