| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01325-1 |
| Product Name/Description |
AQUIOS CL Flow Cytometry System. An in vitro diagnostic medical device (IVD)
Part Number: B30166
All software versions (2.0, 2.0.1 and 2.1)
All applications used on the AQUIOS CL System
ARTG Number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has determined that when AQUIOS CL systems are connected to a Laboratory Information System (LIS), the system may duplicate sample requests leading to sample mis- identification. For this to occur, the following conditions must be met:
- The AQUIOS CL Flow Cytometer is connected to an LIS; and
- The AQUIOS CL system has the DEFAULT TEST enabled; and
- Host Query is enabled in LIS setup screen on system; and
- There are multiple cassettes in the Autoloader; and
- The LIS host query response is received in a brief time window before LIS response timeout occurs.
When all of these conditions are met, a sample will follow two paths of test request creation (LIS and DEFAULT TEST). All software versions (2.0, 2.0.1 and 2.1) in existence are impacted by this issue and all applications used on the AQUIOS CL are impacted by this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users to immediately perform an adjustment to the software options on the system by turning off the DEFAULT TEST. This will eliminate the issue and result in one sample producing one set of results.
After doing this, samples with no LIS test requests will become entries in the incomplete tab.
Beckman Coulter will be contacting laboratories to assist in determining if any samples previously run are impacted.
Please note that recall action RC-2017-RN-01325-1 has been superseded by RC-2017-RN-01489-1 and as such is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |