| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01401-1 |
| Product Name/Description |
DxH 500 Open-Vial Haematology System, with software version 1.0.2 and 1.1. An in vitro diagnostic medical device (IVD)
Reference Number: B40601
ARTG Number 208574 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
An internal investigation has identified that if the Bleach Cycle is interrupted or aborted, the DxH 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis.
Should a Bleach Cycle get interrupted, the subsequent software recovery to perform a Diluter Reset may not be sufficient to prevent the first immediate sample run from being affected. This may result in incorrect patient results.
There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users that if the bleach cycle is interrupted or aborted to ensure the daily shutdown and daily checks are performed prior to running any patient samples. Beckman Coulter will be performing a software update as a permanent correction.
A review of previously generated results is at the discretion of the laboratory director.
This action has been closed out on 07/04/2020
This action has been closed out on 07/04/2020 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |