| TGA Action ID |
RC-2025-RN-00774-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CellMek SPS Sample Preparation System. An in vitro diagnostic medical device (IVD)
Reference number: C44603
All manufactured units |
| ARTG Number |
177999 |
| Unique Device Identifier (UDI) |
15099590750312 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Two problems have been identified that may cause incorrect sample preparation and result in incorrect results from the flow cytometric analysis.
Problem 1:
The dead volumes in Appendix D, Table D.1, in the CellMek SPS Instructions for Use (IFU), for Cassette Types B and E are incorrect. These cassette types are used only with Sarstedt brand tubes.
• Cassette Type B: IFU states 750µl, but actual dead volume is 1582µl; Used with 11mm and 13mm diameter Sarstedt brand tubes.
• Cassette Type E: IFU states 1300µl, but actual dead volume is 2093µl; Used with 15mm diameter Sarstedt brand tubes.
Problem 2:
There's an anomaly with CellMek SPS software that causes the system not to rock Cassette Type E before tubes are pierced for sample preparation. Cassette Type E is used with 15mm X 92mm Sarstedt brand tubes. Rocking the cassettes prior to piercing is needed to ensure specimen homogeneity. |
| Instructions for Customers/Users |
Beckman Coulter will be amending the IFU in the next revision and will address the software anomaly in a future product release.
Meanwhile, customers are read the Customer Letter and:
- For problem 1, use the actual specimen dead volumes stated in Problem Description in the customer letter when processing samples in CellMek SPS with Sarstedt brand tubes.
- For problem 2, not use Cassette Type E (15mm X 92mm Sarstedt brand tubes) to process samples on CellMek SPS.
This action has been closed out on 28/10/2026 |
| Action Commencement Date |
11/09/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Beckman Coulter Australia Customer Service |