Recall Z-1120-2017— Siemens Healthcare Diagnostics, Inc.

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-12-21, terminated 2018-06-07. FDA's recall record names no specific 510(k) clearance for this event. Product: IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 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: Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL..

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-12-21

Terminated

2018-06-07

Firm location

Tarrytown, NY, United States

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