Siemens Healthcare Diagnostics, Inc.: Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.; Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.

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Sources: FDA iRES · Raw API Response

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