Product Wiki · Recalls · Health Canada — Medical Devices

UniCel DxC 600I Synchron Access Clinical Analyzer and Access 2… — recall 52117

Health Canada — Medical Devices · Canada · 2014-10-09 · Type II

As described by Health Canada — Medical Devices: UniCel DxC 600I Synchron Access Clinical Analyzer and Access 2 Immunoassay Systems (2014-09-28)

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Agency
Health Canada — Medical Devices
Recall identifier
52117
Date of alert
2014-10-09
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: Beckman coulter has determined that the Access 2 console PC (B23083) may experience an "MFC exception" error during normal operation. If this error occurs, the system will exit the Access 2 user interface (UI) screen and display a window that notifies the user of a "0==I tubes can count" event. If the UI is re-launched, the system will prevent access to the sample manager screen to request samples for processing and the same "MFC exception" error will occur.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxc-600i-synchron-acces

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