| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01284-1 |
| Product Name/Description |
LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)
LH 750 Haematology System
Part Numbers 6605632 and A85570
LH 780 Haematology System
Part Numbers 723585 and A90728 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
Update: Beckman Coulter's investigation has shown that the LH Cleaner and Coulter Clenz was the main contributor to the optical degradation issue.
Complaints related to optical degradation have increased on the LH 750 and LH 780 Haematology Systems. Customers have reported an increase in LS offset error messages during Startup, Background, control and/or patient analysis.
The optical degradation may potentially cause a delay in reporting results for nucleated red blood cells, white blood cell differential and/or reticulocytes.
CBC panel results are available for reporting and are not affected by this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Update: Beckman Coulter is requesting their customers to discard the affected lot of LH Cleaner. Laboratories can discontinue the additional Clear Flow Cell and Extended Cleaning actions.
Beckman Coulter is recommending users perform a Clear Flow Cell and Extended Cleaning and perform a routine shutdown at least daily. Beckman Coulter is investigating this issue further in order to provide a permanent fix. |
| Contact Information |
1800 090 881 - Customer Support Centre |