ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories

Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively. The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. As defined in t

Siemens sent an Urgent Medical Device Correction Letter dated March 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. .Actions to be Taken by the Customer: To ensure that the patient sample amount for processing is met, follow the requirements for the amount of sample required in the ADVIA 560 Hematology System Operators Guide. Review all patient results for abnormal white blood cell results and process as defined by your lab criteria for abnormal samples and confirm using manual differentials as needed. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please review this letter with your Medical Director. Your Siemens Customer Service Engineer will contact you to schedule time for installation of the 1.4.2333 software when it is available. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (312) 275-7795.