Reported Dec 14, 2016 · Terminated
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
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 SystemsSiemens Material Number (SMN) 11170842IVD
- Lot codes and dates
- All serial numbers of ADVIA 560 Hematology Systems
- Amount recalled
- US: 23 systems; Foreign: 141 systems
Where it was sold
Why it was recalled
Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.
This product could cause temporary or reversible health problems — stop using it.
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