Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens across the entire analytical measuring range (AMR) with the Atellica IM enhanced estradiol (EE2) assay. Results demonstrate that plasma specimens are not meeting claims as defined in the instructions for use (IFU). limited data is available at this time as the investigation for this issue is on-going. Recall start date: Mar 9, 2022
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