COBAS INTEGRA 400 Plus (2020-03-23)

Starting date:

March 23, 2020

Posting date:

April 17, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72827

Last updated: 2020-04-17

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  Reason
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  Affected products

Affected Products

COBAS INTEGRA 400 Plus

Reason

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.

Affected products