| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01259-1 |
| Product Name/Description |
Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems.
Catalogue Numbers: 624519, 179310 and 628026
Multiple Kits and Vial Lot Numbers affected
An in vitro diagnostic device (IVD)
ARTG Number: 223050 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
23/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has received an increased number of customer complaints observed after S-CAL calibration on the Unicel DxH 800 and DxH 600 Coulter Cellular Analysis Systems, and the Coulter LH 750 and LH 780 Hematology Systems.
Customers have reported a variety of issues during calibration including:
- An increase in H&H Check messages
- Low MCH recovery in XB
- Low MCHC recovery in XB
These issues are not observed with all analysers and there is no impact to patient results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users to monitor other quality control performance and adhere to the established maintenance schedule. Beckman Coulter is adjusting the SCAL values for lots starting 4782 and 113160400. This action has been closed-out on 16/05/2017. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |