This page has been archived on the Web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.
Ostase Assay – Beckman Coulter Products
- Starting date:
- November 12, 2012
- Posting date:
- December 24, 2012
- 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-25859
Recalled Products
- Unicel DXI 600 Access Immunoassay System – Ostase Assay
- Access System – Ostase Assay
- Unicel DXI 800 Access Immunoassay System – Ostase Assay
Reason
The access ostase IFU incorrectly specifies the open reagent pack stability as 28 days. The correct open reagent pack stability for this assay is 42 days. The Assay Protocol File (APF) uses the correct open reagent pack stability value.
Affected products
A. Unicel DXI 600 Access Immunoassay System – Ostase Assay
Lot or serial number
All Lots
Model or catalog number
37300
Companies
- Manufacturer
-
Beckman Coulter Inc.
7075 Financial Drive
Mississauga
L5N 6V8
Ontario
CANADA
B. Access System – Ostase Assay
Lot or serial number
All Lots
Model or catalog number
37300
Companies
- Manufacturer
-
Beckman Coulter Inc.
7075 Financial Drive
Mississauga
L5N 6V8
Ontario
CANADA
C. Unicel DXI 800 Access Immunoassay System – Ostase Assay
Lot or serial number
All Lots
Model or catalog number
37300
Companies
- Manufacturer
-
Beckman Coulter Inc.
7075 Financial Drive
Mississauga
L5N 6V8
Ontario
CANADA