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V-Lyte Integrated Multisensor Technology (Imt)
- Starting date:
- April 24, 2017
- Posting date:
- May 16, 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-63316
Reason
Siemens Healthcare Diagnostics has confirmed an increase in complaints regarding elevated urine sodium quality control (QC) exceeding acceptable QC ranges with the Dimension Vista IMT System. Siemens observed a greater urine sodium drift with urine QC than urine patient samples. Not all IMT sensors exhibit the described urine sodium QC drift. Current lots and all future lots are potentially affected until this issue is resolved.
Affected products
V-Lyte Integrated Multisensor Technology (Imt)
Lot or serial number
More than 10 numbers, contact manufacturer
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