| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01089-1 |
| Product Name/Description |
iQ200 Series Analysers and DxU 850m and 840m Iris Analysers. An in vitro diagnostic medical device (IVD).
DxU 850m/840m Microscopy Analysers
Part Numbers: C49513, C76947
iQ200 Series Urine Microscopy Analysers
Part Numbers: 700-3320, 700-3370, 700-3345, 700-3347,C10683, 700-3375, 700-3325, C10684
Rev 2 Flowcell Capsule Spare
Part Number: C04154
iQ Waste Well Adapter
Part Number: 700-3393
ARTG 208574
(Beckman Coulter Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should:
1. Continue to run a complete Quality Control (QC) as directed per iQ200 Series Instructions for Use (IFU) (300-4320 CE or 300-4321 EE) and DxU 850m and 840m Iris IFU (C49320 AB)
2. If the QC passes: Run patient samples as routine.
3. If the QC fails:
* Refer to Chapter 10 Troubleshooting: iQ200 Series IFU or DxU 850m and 840m Iris IFU
* If the failure persists, contact your Beckman Coulter Representative
4. If a "Sequential Flags" Alarm (Alarm#25) displays:
* Refer to Chapter 10; Alarm #25; iQ200 Series IFU or DxU 850 and 840m Iris IFU
* If the alarm persists, contact your Beckman Coulter Representative
Additional weekly action if using DxU 850m/840m Microscopy Analysers:
* Visually inspect the iQClear Rinse Waste Well jets weekly for rust
* If the iQClear shows rust on the rinse jets, contact your Beckman Coulter Representative
Consult with your laboratory management to determine whether a retrospective review of results is necessary.
This action has been closed out on 18/3/2024. |
| Contact Information |
1800 060 881 - Customer Support Centre |