ADVIA 560 Hematology Analyzer

Starting date:

October 22, 2016

Posting date:

November 9, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-60950

• Reason
• Affected products

Affected Products

Reason

Siemens is investigating an issue on the ADVIA 560 Hematology System which may cause an incorrect result to be reported. Siemens has received two reports of multiple discordant records for the same sample ID (SID) 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.

Affected products