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Access Immunoassay Systems (by Beckman Coulter)
- Starting date:
- January 7, 2013
- Posting date:
- February 4, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-17207
Recalled Products
- Unicel DXI 800 Access Immunoassay System - PAPP-A Assay
- Access Immunoassay Sys - PAPP-A (Pregnancy Associated Plasma Protein) Assay
- Unicel DXI 600 Access Immunoassay System - PAPP-A System
Reason
Beckman Coulter, Inc. (BEC) has identified that two access PAPP-A Quality Control (QC) lots (120380, 122262) may generate mean values below the mean values stated on the QC cards. The average difference observed in BEC's internal investigation was 11% below the stated mean. The results observed may vary based on the combination of reagent and calibrator lots in use. Reduced QC could lead to repeat testing and a potential delay in reporting patient results.
Affected products
A. Unicel DXI 800 Access Immunoassay System - PAPP-A Assay
Lot or serial number
120380, 122262
Model or catalog number
A48573
Companies
- Manufacturer
- Beckman Coulter Inc.
B. Access Immunoassay Sys - PAPP-A (Pregnancy Associated Plasma Protein) Assay
Lot or serial number
120380, 122262
Model or catalog number
120380, 122262
Companies
- Manufacturer
- Beckman Coulter Inc.
C. Unicel DXI 600 Access Immunoassay System - PAPP-A System
Lot or serial number
120380, 122262
Model or catalog number
A48573
Companies
- Manufacturer
- Beckman Coulter Inc.