Product Wiki · Recalls · Health Canada — Medical Devices

Sysmex Blood Coagulation Analyzer CA-620 and CA-660 (2017-06-20) — recall 56988

Health Canada — Medical Devices · Canada · 2017-07-17 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56988
Date of alert
2017-07-17
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: Sysmex Corporation has informed Siemens Healthcare Diagnostics Products Gmbh about a phenomenon affecting CA Series Systems. Under rare circumstances there is a potential the system might fail to alert the operator about an individual sample ID number assigned to multiple patient measurement results when using the built-in barcode scanner. Under very rare circumstances this may lead to an incorrect diagnostic and patient treatment decision due to potential of a mismatched result for the patient.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sysmex-blood-coagulation-analy

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