Cobas Integra Fructosamine (2019-11-11)

Starting date:

November 11, 2019

Posting date:

November 22, 2019

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-71678

Last updated: 2019-11-22

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  Reason
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  Affected products

Affected Products

Cobas Integra Fructosamine

Reason

During internal reagent testing it was shown that the linearity claim of the 1000umol/ml for the cobas Integra Fructosamine used on cobas Integra 400 Plus Analyzer could not be achieved anymore. As a consequence, the manufacturer reduced the upper measuring range to 900umol/l. The manufacturer advised us of this issue on 2019/10/28.

Affected products