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