Product Wiki · Recalls · Health Canada — Medical Devices

Access system recalls — recall 48435

Health Canada — Medical Devices · Canada · 2012-11-26 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
48435
Date of alert
2012-11-26
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: Potential problem with the 10-Tooth (10T) and 14-Tooth (14T) Mixer Pulley Assemblies in the access family of Immunoassay systems. It has been determined that in some cases, pulley drive components have broken parts or have become loose, mis-positioned, or disconnected from their drive. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate mixing of the contents of the reaction vessel which can lead to erroneous test results.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/access-system-recalls

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