Class 2 Device Recall Siemens ADVIA 560 Hematology Systems

• Date Initiated by Firm: March 10, 2016
• Create Date: April 20, 2016
• Recall Status: Terminated on June 07, 2018
• Recall Number: Z-1500-2016
• Recall Event ID: 73588
• 510(K)Number: K111534
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: 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
• Code Information: All serial numbers of ADVIA 560 Hematology Systems.
• FEI Number: 2432235
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Customer Care Center; 312-275-7795
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Process design
• Action: 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.
• Quantity in Commerce: US: 8 systems; Foreign: 64 systems
• Distribution: Worldwide Distribution - US Distribution including Puerto Rico and to the states of : California, Illinois, Washington and Wisconsin., and to the countries of : Angola, Austria, Canada, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Kenya, Netherlands, Norway, Portugal, Singapore, Slovenia, Spain, Turkey, Uganda and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GKZ