Product Wiki · Recalls · Health Canada — Medical Devices

Dimension Vista System - A1-Antitrypsin Assay (2018-05-22) — recall 61019

Health Canada — Medical Devices · Canada · 2018-06-06 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
61019
Date of alert
2018-06-06
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens is notifying customers to advise of a high rate of calibration failure for Dimension Vista Flex reagent cartridge A1AT lot 17279MA. The calibration failure is due to a Mean Absolute Relative Deviation (MARD = Percent Deviation) > 5% for the instrument's automatic calibration acceptance criterion. Siemens Healthcare Diagnostics Products GmbH is currently investigating this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-system-a1-anti

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