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UniCel DxI 600 Access Immunoassay System — recall 44552

Health Canada — Medical Devices · Canada · 2019-05-03 · Type III

As described by Health Canada — Medical Devices: UniCel DxI 600 Access Immunoassay System - Intrinsic Factor AB (2019-04-13)

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Agency
Health Canada — Medical Devices
Recall identifier
44552
Date of alert
2019-05-03
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Beckman Coulter has determined for the Access Intrinsic Factor Antibody (IFab) assay that in rare cases a "negative" result interpretation, rather than "equivocal", is assigned when the result is between 1.20 and 1.2000000476 AU/mL.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-access-immunoas

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