Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 8/17/2016
Class lI:
PRODUCT
Stratus CS STAT Fluorometric Analyzer-microproc essor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
Recall Number Z-2525-2016
REASON
Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc. , Norwood, MA on 6/22/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
977 units
DISTRIBUTION
Nationwide and Internationally
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