| TGA Action ID |
RC-2026-RN-00734-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SW-40 and SW-41 Rotors in Optima. An in vitro diagnostic medical device (IVD).
ROTOR ASSY-SW40
REF: 331302
Serial Numbers: 24U15260 to 26U15764
ROTOR ASSY-SW41
REF: 331362
Serial Numbers: 24U15250 to 26U15766 |
| ARTG Number |
177999 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use.
Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.
In all confirmed complaints of rotor breakage, the Ultracentrifuge contained the incident and there was no risk of exposure to physical or mechanical energy hazards. |
| Instructions for Customers/Users |
- If another compatible rotor is available with an unaffected Serial Number, discontinue use of the affected rotor(s) and use the alternative rotor until a replacement rotor is received. A description of the compatible rotors is available in the instrument Instructions for Use.
- If no alternative compatible rotor is available and continued use is necessary, customers may continue to use the current rotor until a replacement rotor is received; however, continued use carries a possibility of rotor breakage which may result in significant damage to materials being run in the centrifuge and the centrifuge instrument.
- Customers should contact a service representative if they experience rotor breakage. Customers should use personal protective equipment, and standard laboratory operating procedures for the handling of biohazardous materials when opening the centrifuge to prevent exposure to damaged materials.
- Return the completed Customer Response Form to Beckman Coulter, and a representative will coordinate a replacement order. |
| Action Commencement Date |
24/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Beckman Coulter |