Recall Z-0885-2017— Siemens Healthcare Diagnostics, Inc.

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-11-18, terminated 2018-06-07. FDA's recall record names no specific 510(k) clearance for this event. Product: IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.. Reason: 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..

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-11-18

Terminated

2018-06-07

Firm location

Tarrytown, NY, United States

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