| TGA Action ID |
RC-2025-RN-00958-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Access 2 Reaction Vessels. An in vitro diagnostic medical device (IVD).
REF: 81901
Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004, P250005
UDI: 15099590180249 |
| ARTG Number |
229315 |
| Unique Device Identifier (UDI) |
15099590180249 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Beckman Coulter has identified that affected lots of Access 2 Reaction Vessels (RV) may contain manufacturing deformities. The bottom (round end) of the RV may have a small protrusion or hair like deformity.
The deformed RVs may cause an increased rate of instrument errors, putting the instrument in a Not Ready mode, and delay processing of patient samples. |
| Instructions for Customers/Users |
Customers are to:
- Check inventory for affected lots.
- Contact Beckman Coulter for replacement RVs.
- Affected lots may continue to be used until sufficient replacement RVs have been supplied, then the affected lots can be destroyed.
Retrospective review of results is not necessary as this issue does not affect individual patient results.
This action has been closed out on 12/02/2026. |
| Action Commencement Date |
12/11/2025 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Customer Administration Services |