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Dimension Vista V-LYTE Integrated Multisensor Na+ / K+ / Cl-
- Starting date:
- December 22, 2016
- Posting date:
- January 12, 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-61768
Reason
Siemens Healthcare Diagnostics has confirmed a low bias for dimension Vista V-Lyte integrated Multisensor Urine Potassium when compared to the dimension QuikLyte Integrated Multisensor, which is the predicate device used in the method comparison section of the v-lyte instructions for use (IFU). Please note, serum/plasma potassium results are not affected by this issue as there are separate parameters for serum/plasma potassium.
Affected products
Dimension Vista V-LYTE Integrated Multisensor Na+ / K+ / Cl-
Lot or serial number
6HD866
6KD873
6KD875
6KD877
Model or catalog number
K800A
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES