Dimension Vista System - A1-Antitrypsin Assay (2018-05-22)

Starting date:

May 22, 2018

Posting date:

June 6, 2018

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-66980

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  Reason
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  Affected products

Affected products

Dimension Vista System -A1-Antitrypsin Assay

Reason

Siemens is notifying customers to advise of a high rate of calibration failure for Dimension Vista Flex reagent cartridge A1AT lot 17279MA. The calibration failure is due to a Mean Absolute Relative Deviation (MARD = Percent Deviation) > 5% for the instrument's automatic calibration acceptance criterion. Siemens Healthcare Diagnostics Products GmbH is currently investigating this issue.

Affected products