This page has been archived on the Web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 RF Flex Reagent Cart. (2013-07-19)
- Starting date:
- July 19, 2013
- Posting date:
- September 27, 2013
- 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-35889
Recalled products
A. Dimension Vista RF Flex Reagent Cartridge
Reason
Siemens has confirmed an increase in the rate of abnormal assay errors (E143: abnromal assay) with the Dimension Vista RF Flex reagent cartridge, lot 12283MA. The errors can occur on calibration, QC and/or patient sample. Any result produced with the abnormal assay error is deemed non-reportable.
Affected products
A. Dimension Vista RF Flex Reagent Cartridge
Lot or serial number
- 12283MA
Model or catalog number
- 10445908
- K7068
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str. 76
Marburg
35041
GERMANY