| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00423-1 |
| Product Name/Description |
UniCel (DxH 800/DxH 600/ DxH Slidemaker Stainer) Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD)
UniCel DxH 800 Coulter Analysis System
Reference # 629029, B24465, B24802, B68304
Software versions: 2.0.0.0 & greater
UniCel DxH 600 Coulter Cellular Analysis System
Reference # B23858
Software versions: 1.0.0.0 & greater
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
Reference # 775222
s/w versions: 1.5.0.0 & greater
ARTG # 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The DxH 800, DxH 600, and DxH Slidemaker Stainer may fail to notify the user of warnings or error conditions for low or depleted reagent conditions, Daily Checks failures, LIS disconnection, and Printer failures at:
· The Alert Status icon(s) on the System Manager
· The audible alarm at the System Manager
· The instrument beacon on the Specimen Processing Module or Slidemaker Stainer
The failure may occur when the System Manager application is restarted or powered OFF/ON.
When the failure occurs the user may not notice the need to change reagents before depletion, instrument operation will continue and, information about reagent levels shown on the Supplies screen, results on the Daily Checks screen, and the status of the LIS connection and Printer on the System Status screen are correct. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users to monitor the reagent levels and status on the reagent Supplies screen. The ‘Cycles Remaining’ field is located at the bottom of the screen, above the local navigation buttons. The field will be highlighted yellow (warning) or red (error) when a reagent is low or depleted. Users should monitor the status of the LIS and/or Printer using their graphics on the System Status screen. Red, grey, or black status spheres within a graphic indicate possible concerns. A software correction will in implemented as a permanent fix.
This action has been closed out on 19/10/2018 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |