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Dimension Vista System Prot 1 Con and Cal (2017-05-31)
- Starting date:
- May 31, 2017
- Posting date:
- July 6, 2017
- 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-63802
Affected Products
A. Dimension Vista System Prot1 Con
B. Dimension Vista System Prot1 Cal
Reason
Siemens Healthineers has confirmed a negative bias of approximately -20% for results obtained with Dimension Vista CER Flex Reagent Cartridge when calibrating CER with affected PROT 1 CAL lots. PROT 1 controls for CER are similarly biased.
Affected products
A. Dimension Vista System Prot1 Con
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
KC715
KC716
KC717
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY
B. Dimension Vista System Prot1 Cal
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
KC710C
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY