Product Wiki · Recalls · Health Canada — Medical Devices

UniCel DxI 600, 800 Access Immunoassay System — recall 59020

Health Canada — Medical Devices · Canada · 2019-03-08 · Type III

As described by Health Canada — Medical Devices: UniCel DxI 600, 800 Access Immunoassay System - Thyroglobulin Antibody II (2019-02-09)

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Agency
Health Canada — Medical Devices
Recall identifier
59020
Date of alert
2019-03-08
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Beckman Coulter has determined through customer feedback and an internal investigation that the four affected access thyroglobulin antibody II (TgAbII) reagent lots may generate falsely decreased results in some patient samples when compared to previously released reagent lots. The affected lots of TgAbII reagent have been shown to generate repeatable (falsely decreased) results by up to 95% in some patient samples.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-800-access-immu

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