AQT90 FLEX Analyzers (2020-12-01)

Starting date:

December 1, 2020

Posting date:

December 24, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74645

Last updated:
2020-12-24

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  Reason
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  Affected products

Affected Products

AQT90 FLEX Analyzers

Reason

Radiometer have received an increasing number of customer complaints that have triggered the investigation and identification of a data integrity problem on aqt90 Flex Analyzers with a e3800 PC unit installed.The data integrity problem observed on aqt90 Flex Analyzers with a e3800 PC unit installed can give wrong time stamp on test results. All aqt90 Flex parameters are affected and can give: (1) error in documentation and (2) incorrect time interval between measurements.

Affected products