Siemens—ADVIA Centaur Herpes2 IgG Kits: May Yield False-Positive Results

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FDA's Center for Devices and Radiological Health (CDRH) states that the above products may yield false-positive herpes simplex virus (HSV) results and do not meet the 60-day onboard stability or the 28-day calibration frequency interval. FDA's CDRH further states that the manufacturer initiated a recall by Urgent Medical Device Correction letter in February 2021. Siemens states that this problem was identified through internal investigation and shows that an increase in Index values with quality control (QC) and patient samples may be observed over the 60-day period while the reagents are onboard the system. For some samples, a positive bias of up to 69% in Index values was observed with a 60-day onboard stability and 28-day calibration interval. Siemens also states that its testing has shown 95% qualitative agreement over the 60-day onboard...