Recall Z-1532-2014— Siemens Healthcare Diagnostics

Class II FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2013-12-20, terminated 2017-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum.. Reason: Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue..

Recalling firm

Siemens Healthcare Diagnostics

Classification

Class II

Status

Terminated

Initiated

2013-12-20

Terminated

2017-02-28

Firm location

Tarrytown, NY, United States

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