Recall Z-2525-2016 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
Siemens Healthcare Diagnostics Inc
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
| Date | Jun 22, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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 |
| Quantity | 977 units |
| Distribution | Worldwide Distribution -- USA, U.A.E., Algeria, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Canada, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Namibia, P.R. China, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984067 | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK Dade Behring, Inc., Jan 13, 1999 |