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DIMENSION VISTA SYSTEM - HCYS FLEX REAGENT (2016-05-24)
- Starting date:
- May 24, 2016
- Posting date:
- June 13, 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, Hospitals, Healthcare Professionals
- Identification number:
- RA-58838
Affected products
A. DIMENSION VISTA SYSTEM - HCYS FLEX REAGENT
Reason
Siemens Healthcare Diagnostics has confirmed that the Dimension Vista Flex HCYS reagent cartridge catalog # K7044, lot number 15243MA shows a reduced open well stability that does not meet the claimed time frame. As a consequence QC recoveries can be found below the assigned ranges, giving invalid runs that may prompt customers to a new calibration.
Affected products
A. DIMENSION VISTA SYSTEM - HCYS FLEX REAGENT
Lot or serial number
15243MA
Model or catalog number
10445897
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Gmbh
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY