Device 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
Z-1500-2016
Product summary
- Event
- Event 73588
- Status
- Terminated
- Classification
- Class II
- Quantity
- US: 8 systems; Foreign: 64 systems
- Official record key
device-enforcement:Z-1500-2016
Official wording
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
Code information: All serial numbers of ADVIA 560 Hematology Systems.
Distribution pattern: 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.
Derived failure modes
-
Device software or design
Software anomaly