Product Wiki · Recalls · Health Canada — Medical Devices

COBAS INTEGRA 400 Plus (2020-03-23) — recall 63334

Health Canada — Medical Devices · Canada · 2020-04-17 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 63334
Date of alert: 2020-04-17
Country / jurisdiction: Canada
Risk level: Type III
Risk type: recall
Product category: Medical devices
Product type: Medical devices

Reported risk: The manufacturer confirmed that the ceruloplasmin test used on the COBAS INTEGRA 400 Plus instrument may lead to elevated recoveries. The ceruloplasmin test used on the COBAS C instrument is not impacted by this issue. The manufacturer advised us of this issue on 19-Mar-2020.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-integra-400-plus-2020-03

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COBAS INTEGRA 400 Plus (2020-03-23) — recall 63334

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