| TGA Action ID |
RC-2026-RN-00886-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CN-3000 System and CN-6000 System. An in vitro diagnostic medical device (IVD).
CN-3000 System
Material Numbers: 11554200, 11694236
CN-6000 System
Material Numbers: 11374900, 11694234 |
| ARTG Number |
179939 |
| Unique Device Identifier (UDI) |
004987562499700, 004987562518616, 004987562499687, 004987562518630 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Sysmex identified that deposits may accumulate on the Sample Arm B probe of the CN-Series analysers. The deposits may affect sample dispensing, potentially resulting in the delivery of a lower sample volume to the reaction cuvette than defined, which may cause falsely decreased results.
Based on the manufacturer’s investigation, the accumulation of deposits occurred due to insufficient washing of the Sample Arm B probe independent from the assays used.
Falsely low results may lead to delayed diagnosis, incorrect exclusion of thromboembolic disease and withholding anticoagulation therapy, unnecessary increase in drug dosage, or an increased risk for major bleeding complications.
Sysmex has received seven complaints worldwide associated with this problem. As of 15 October 2026, no patient harm has been reported in connection with these complaints. |
| Instructions for Customers/Users |
Customers are to:
- Implement mandatory manual cleaning processes at least once a week or every 16,000 tests, whichever comes first. Instructions for users on cleaning the Sample Arm B probe are providing in the customer letter's Annex.
- Review the letter with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
- Contact their local Siemens Healthineers if they experience this problem and are not able to solve it by the actions provided.
A follow up communication will be provided once the customer actions are no longer required, and a software update is being developed to enhance the automated cleaning of the probe. |
| Action Commencement Date |
4/11/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |