Product Wiki · Recalls · Health Canada — Medical Devices

Unicel Dxi 600 and 800 Access Immunoassay Br Monitors (2017-04-14) — recall 56965

Health Canada — Medical Devices · Canada · 2017-05-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56965
Date of alert
2017-05-16
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: Following biases observed in the results of the French national quality controls, Beckman Coulter has been informed that a study completed by the French competent authority Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 u/ml as stated in the access BR monitor instructions for use (IFU).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-and-800-access-

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