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Dimension Vista System PROT1 CON
- Starting date:
- October 28, 2016
- Posting date:
- November 15, 2016
- 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-61048
Affected Products
Reason
Siemens Healthcare Diagnostics has confirmed that control values PROT1 CON H may be found out of range ( >+/- 15%) for Dimension Vista PREALB Flex Reagent Cartridge leading to invalid runs. We have no indication that other analytes in PROT1 CON H are affected by this issue.
Affected products
Dimension Vista System PROT1 CON
Lot or serial number
- 5LHQ01B
- 5LQH01
- 5LQH01A
- 5LQH01C
Model or catalog number
- KC717
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY