| TGA Action ID |
RC-2025-RN-01093-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CellMek SPS Sample Preparation System. An in vitro diagnostic medical device (IVD)
Software Version 2.3.90.0.
Ref: C44603 & D27513 |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
C44603-15099590750312, D27513-15099590802110 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Beckman Coulter has confirmed an error in SW Version 2.3.90.0 that causes samples to be dispensed unexpectedly close to the bottom of the output tubes. The intended design is for samples to be dispensed above the fluid surface into the output tubes.
When using output tubes not supplied by Beckman Coulter, this problem may lead to contact between the dispense probe and the tube bottom. The resultant pressure has the potential to dislodge the system fluid line, which could result in loss of in-process samples, sample spillage on instrument workspace, and render the instrument inoperable.
For all output tube types, this problem will lead to 60 to 100µl being unintentionally removed from the final sample, resulting in reduced volume available for flow analysis
In a worst-case scenario, loss of in-process sample when beads are manually added to the sample after processing by CellMek SPS may lead to erroneously low absolute count determination. If not recognised by the flow cytometry technologist and pathologist during the analysis, this may result in mischaracterisation or enumeration of cellular populations. The physician may make an incorrect diagnosis or an error in the management and treatment of a patient. |
| Instructions for Customers/Users |
Beckman Coulter will perform an on-site modification to update the instrument software to correct this problem.
In the interim:
• To mitigate the risk of contact between the dispense probe and the tube bottom, utilise CellMek SPS output tubes distributed by Beckman Coulter.
• For absolute count assays, use the CellMek SPS on-board counting bead feature. Do not add counting beads to samples manually after preparation with CellMek SPS.
This action has been closed out on 13/04/2026 |
| Action Commencement Date |
2/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Customer Administration Services |