Health product recall

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

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

Dimension Vista System -A1-Antitrypsin Assay

Lot or serial number

17279MA

Model or catalog number

K7014

Companies
Manufacturer
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY