Field Safety Notice: Siemens Healthcare Diagnostics ADVIA Centaur Systems PSA Assay

vrijdag 22 januari 2016 16:00

Siemens Healthcare Diagnostics has confirmed that the lots listed in Table 1 of the ADVIA Centaur Systems Prostate Specific Antigen (PSA) assay are not meeting the current High-Dose Hook Effect expectation in the Instructions for Use (IFU). The ADVIA Centaur Systems PSA Assay Range is 0.01–100 ng/mL (?g/L).