Field Safety Notice: Siemens Healthcare Diagnostics, IMMULITE®/ IMMULITE® 1000 and IMMULITE® 2000/ IMMULITE®

dinsdag 27 december 2016 0:00

Siemens Healthcare Diagnostics has confirmed that the IMMULITE®/ IMMULITE® 1000 and IMMULITE® 2000/ IMMULITE® 2000 XPi Prostate Specific Antigen (PSA) assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use (IFU).