Product Wiki · Recalls · Health Canada — Medical Devices

Immunoglobulin M, A & G for use on COBAS INTEGRA 400/400 Plus/800… — recall 63403

Health Canada — Medical Devices · Canada · 2020-05-08 · Type III

As described by Health Canada — Medical Devices: Immunoglobulin M, A & G for use on COBAS INTEGRA 400/400 Plus/800 analyzers & Ceru (Ceruloplasmin) (2020-04-03)

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Agency
Health Canada — Medical Devices
Recall identifier
63403
Date of alert
2020-05-08
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: In order to comply with the prerequisites of IVDR and due to the data basis available for registration, the manufacturer revised the method sheets and application settings for the ceruloplasim, immunoglobulin A, immunoglobulin G and immunoglobulin M assays by removing post-concentration via the rerun function. The manufacturer advised us of this issue on 21-Mar-2020.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/immunoglobulin-m-g-use-cobas-i

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