| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00500-1 |
| Product Name/Description |
Access BR Monitor. An in vitro diagnostic medical device (IVD)
Reference Number: 387620
All non-expired lots and future lots
ARTG Number: 213975 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has been informed that a study completed by the French Competent Authority 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). The ANSM’s preliminary study demonstrated that 10 out of 27 patients diagnosed with cancer in non-remission had a result below the Access BR Monitor URL. In this preliminary study, at the cutoff of 31.3 U/mL designated in the Access BR Monitor IFU, the assay achieved a sensitivity of 63% and a specificity of 100% for patients in non-remission.
As a result, Beckman Coulter is evaluating the Access BR Monitor cutoff. The conclusions of this evaluation are planned to be available by the third Quarter of 2017. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users that they are currently evaluating the Access BR Monitor cutoff. Users are reminded of the limitations of the assay which are included the current IFU and detailed in the customer letter. These relate to the intended use of the assay as an aid in the management of breast cancer patients and not as a screening tool, the interpretation of CA 15-3 antigen concentration results and the laboratory's establishment of reference ranges to assure proper representation of specific populations.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Technical Support Centre |