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Access System,Unicel DXI 600 Access Immunoassay System and Unicel DXI 800 Access Immunoassay System-Total BhCG assay (2014-04-10)
- Starting date:
- April 10, 2014
- Posting date:
- June 5, 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-39777
Recalled products
- Access System - Total BhCG assay
- Unicel DXI 600 Access Immunoassay System - Total BhCG Assay
- Unicel DXI 800 Access Immunoassay System - Total BhCG Assay
Reason
Beckman coulter has confirmed from customer feedback and internal testing that the access total Beta-hCG assay reagent lot 325497 may not meet the total imprecision claim of 10% CV at values less than 20 mIU/ml.
Affected products
A. Access System - Total BhCG assay
Lot or serial number
- 325497
Model or catalog number
- 33500
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
B. Unicel DXI 600 Access Immunoassay System - Total BhCG Assay
Lot or serial number
- 325497
Model or catalog number
- 33500
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES
C. Unicel DXI 800 Access Immunoassay System - Total BhCG Assay
Lot or serial number
- 325497
Model or catalog number
- 33500
Companies
- Manufacturer
-
Beckman Coulter Inc.
250 S. Kraemer Blvd.
Brea
92821
California
UNITED STATES