Recall Z-1500-2016 ยท GKZ Counter, Differential Cell
Siemens Healthcare Diagnostics, Inc.
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
| Date | Mar 10, 2016 |
| Status | Terminated |
| Reason | 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 |
| Root 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. |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111534 | ABACUS 3CP Diatron U.S., Inc., Aug 2, 2012 |