This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
DIMENSION VISTA SYSTEM - CHEM CALIBRATORS (2016-03-01)
- Starting date:
- March 1, 2016
- Posting date:
- March 11, 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-57486
Affected Products
DIMENSION VISTA SYSTEM - CHEM CALIBRATORS
Reason
Siemens Healthcare Diagnostics has received complaints of "calibrator insert missing" alerts on Dimension Vista Chemistry 3 Calibrator lot 5md004. Internal investigation has confirmed that the vial barcode label reads KC130 instead of the correct catalog number KC130A. When this mismatch occurs between the vial barcode label and the Instructions For Use (IFU) label, the "calibrator insert missing" error is triggered and displayed on the Dimension Vista instrument screen. There is no risk of erroneous results when this issue occurs as no results are generated.
Affected products
DIMENSION VISTA SYSTEM - CHEM CALIBRATORS
Lot or serial number
- 5MD004
Model or catalog number
- KC130A
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Alabama
UNITED STATES