| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00808-1 |
| Product Name/Description |
Access Unconjugated Estriol. An in vitro diagnostic medical device (IVD).
REF: 33570
Lots 921133, 921348 and 921742
ARTG 213976
(Beckman Coulter Australia Pty Ltd - Clinical chemistry hormone IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/09/2020 |
| Responsible Entity |
|
| Reason/Issue |
Customer feedback has helped Beckman Coulter identify and characterize the potential for higher than expected bovine-ALP associated interference in patient samples tested with the Access uE3 assay for specific lots.
An internal investigation of ~300 samples confirmed that up to 3% of patient samples may demonstrate bovine-ALP associated interference.
The frequency and mechanism of bovine-ALP associated interference is specific to the Access uE3 assay.
This interference is not associated with patient sample endogenous ALP levels. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Beckman Coulter is actively working to resolve this issue by end of Q1, 2021.
In the interim, customers are advised to:
· Consider the patient’s total clinical presentation when interpreting results.
· Any retrospective review of patient results is left to the discretion of the Medical Director.
· Contact Beckman Coulter Technical Support if ALP associated interference is suspected and do not report the uE3 test result.
This action has been closed out on 11/03/2021 |
| Contact Information |
1800 060 881 - Customer Support Centre |