| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01142-1 |
| Product Name/Description |
Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical device (IVD)
Multiple Lot Numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
The affected Access hLH Calibrator lots do not meet the stated expiration date claim. As a result, the quality control and patient sample results generated while using these calibrator lot numbers might be falsely elevated by as much as 13%. This can occur up to four months prior to the expiration date listed on the calibrator vial. |
| Recall Action |
Recall |
| Recall Action Instructions |
Beckman Coulter is advising users to discontinue the use of the affected calibrator and is providing updated work around instructions to mitigate the issue. Clinicians/research scientists should be notified regarding potentially affected results at the discretion of the Laboratory Director. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |