| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01049-1 |
| Product Name/Description |
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
Part number: 775222
All software revisions
ARTG number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has received and confirmed a report of a fire within the Stainer module of a customer’s DxH Slidemaker Stainer. The fire was fully contained within the Stainer module. The event was preceded by a significant increase in the frequency of the automatic top-off of the module’s methanol bath.
Users are being advised to discontinue use of the Stainer module to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.
Beckman Coulter is actively investigating the reported incident to determine the root cause, and define and implement required corrective and preventive actions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users to:
1. Immediately discontinue use of the Stainer module.
2. Drain all liquids from the Stainer module.
3. Follow the directions provided for placing the Stainer module in extended shutdown and disabling the Stainer.
Once the Stainer has been disabled, the Slidemaker module may be used to prepare slides for staining. Slides must be stained using an alternative method.
A Beckman Coulter service representative will schedule a visit to modify the Stainer module so that it remains disabled and cannot be used until further corrective action is implemented. This action has been closed-out on 02/03/2017. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Technical Support Centre |