| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01360-1 |
| Product Name/Description |
Access BR Monitor used with the Access family of Immunoassay systems. An in vitro diagnostic medical device (IVD)
Reference Number: 387620
Lot Numbers:
623913 (exp 31 May 2017)
625701 (exp 30 Aug 2017)
628771 (exp 30 Sep 2017)
630349 (exp 31 Jan 2018)
633070 (exp 28 Feb 2018)
723522 (exp 31 Mar 2018)
723523 (exp 30 Apr 2018)
723741 (exp 30 Jun 2018)
723916 (exp 31 Jul 2018)
All future lots
ARTG Number: 213975 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
In April 2017 (TGA reference RC-2017-RN-00500-1) Beckman Coulter advised customers of issues with the Access BR Monitor relating to results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor Instructions For Use (IFU).
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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.
This action has been closed out on 17/10/2018 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |