Stratus CS STAT Fluorometric Analyzer-microprocessor-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

Siemens Healthcare issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on June 22, 2016 both in the United States and Outside the US for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions. Customers are to contact Siemens Customer Care Center or their local Siemens technical support representative at 800-405-6473. Siemens Healthcare is currently developing a software update to address this issue and will be providing new information as it becomes available