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Dimension Vista System-Prealbumin Assay
- Starting date:
- February 7, 2017
- Posting date:
- February 27, 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-62384
Reason
Siemens Healthcare Diagnostics has confirmed a high calibration failure rate (percent deviation >5%) with PREALB FLEX REAGENT Cartridge Lot 15327MA. This is due to the VISTA PREALB Calibration Level 6 exhibiting a high bias and leading to failed calibrations.
Affected products
Dimension Vista System-Prealbumin Assay
Lot or serial number
15327MA
Model or catalog number
K7064
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY