Product Wiki · Recalls · Health Canada — Medical Devices

Dimension Vista System PROT1 CON — recall 56065

Health Canada — Medical Devices · Canada · 2016-11-15 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56065
Date of alert
2016-11-15
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Siemens Healthcare Diagnostics has confirmed that control values PROT1 CON H may be found out of range ( >+/- 15%) for Dimension Vista PREALB Flex Reagent Cartridge leading to invalid runs. We have no indication that other analytes in PROT1 CON H are affected by this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-system-prot1-c

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