This page has been archived on the Web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-Hemoglobin A1C (HBA1C) A (2014-08-19)
- Starting date:
- August 19, 2014
- Posting date:
- August 28, 2014
- 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-41237
Recalled products
- Dimension Vista System-Hemoglobin A1C (HBA1C) A
Reason
An internal study has shown that variance is introduced into the percentage of HBA1C result when the sample is run from the small sample container (SSC). Previously (VC-14-03) cyclosporine was identified as under-recovering when run from the SSC. CAPA investigation has found that an unintentional dilution of the sample occurs when whole blood samples are transferred from the SSC to the aliquot well. The percentage of HBA1C is a ration of two components. With the percentage of HBA1C, the unintentional dilution of sample introduces variance into the final percentage of HBA1C result.
Affected products
A. Dimension Vista System-Hemoglobin A1C (HBA1C) A
Lot or serial number
- 13273BA
- 13294BA
- 13308BA
- 13329AA
- 13350AA
- 14006AA
- 14041BA
- 14132BA
Model or catalog number
- 10470481
- K3105A
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES