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ADVIA 560 Hematology Analyzer — recall 56040

Health Canada — Medical Devices · Canada · 2016-11-09 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56040
Date of alert
2016-11-09
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-560-hematology-analyzer

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