| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00063-1 |
| Product Name/Description |
RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP)
(An in vitro diagnostic medical device)
RT12 Tube Rotor-Kit (RT12) Catalogue Number: RT12-KIT (REF x00-006152-001), Product Labeling: 54-006155-001
StatSpin MP Centrifuge Catalogue Number: SSMP (REF x00-004998-001), Product Labeling: 55-001806-001H
All Serial Numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Iris International (the manufacturer) has received reports of uncontained debris (part fragments) as a result of rotor breakage and lid failures on similar centrifuge models which use the RT12 rotor and shield. A shield was implemented on similar models and this notification is to inform SSMP users that the shield must be used when operating the centrifuge. There have been no reports of the StatSpin MP Centrifuge failing to contain debris when users operate StatSpin MP centrifuges according to the StatSpin MP Operator’s Manual (Doc # 55-001806-001) and RT12 Tube Rotor Instructions (Doc # 54-006155-001). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
ThermoFisher is providing additional maintainance instructions and updated operators manual. The information included is intended to supplement the current SSMP Operator Manual.
This action has been closed out on 15/11/2018 |
| Contact Information |
02 8817 4279 - ThermoFisher |