Diagnostica Stago, Inc. device recall (Cls II)

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable — Reason: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. — Status: Ongoing