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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 014 05 17 001
Date submitted: 10/31/2017
Manufacturer:Beckman Coulter
Device Type:Access BR Monitor used with the Access Family of Immunoassay Systems
Description:IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly
Medical Device Identifier:REF No.: 387620
LOT : All Non-Expired Lots and Future Lots
Reason of Field Safety Corrective Action:Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de sécurité du Medicament et des produits de santé (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).
Remedy Action:Ensure your laboratory staff and clinicians are aware of the following limitations of the Access BR Monitor assay found in the IFU:
-The Access BR Monitor Assay should not be used as a cancer screening tool. A value below the cutoff limit does not indicate the absence of breast cancer.
-Serum or plasma CA 15-3 antigen concentrations should not be interpreted as absolute evidence for the presence or absence of cancer.
-This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for CA 15-3 antigen concentrations using Access BR Monitor assay should be used in conjunction with other clinical methods for monitoring breast cancer.
-The Access BR Monitor results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information.
-Values obtained with different assay methods cannot be used interchangeably. The concentration of CA 15-3 antigen in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity.
-Each laboratory should establish its own reference ranges to assure proper representation of specific populations.


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TGA Update Action:
As a follow up, Beckman Coulter will update the Access BR Monitor Instructions for Use (IFU). The updated IFU will reflect the 95th percentile upper reference limit (URL) value for a healthy population, which was determined to be 23.5 U/mL. There is no change to the Access BR Monitor assay.
Beckman Coulter is advising users of the updated 95th percentile upper reference limit (URL) value for a healthy population, which is 23.5 U/mL. Beckman Coulter is recommending that users review the contents of this letter with the Laboratory Medical Director. This URL change may mean that some patient test results should be reassessed depending upon how the URL is established by the laboratory.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR, TGA :http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01360-1
Source Ref. Number:22506FEB4F21B , TGA : RC-2017-RN-01360-1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments