Reported Apr 27, 2016 · Terminated
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- 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
- Lot codes and dates
- All serial numbers of ADVIA 560 Hematology Systems.
- Amount recalled
- US: 8 systems; Foreign: 64 systems
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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