| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00663-1 |
| Product Name/Description |
Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)
(used on StreamLAB Centrifuges, Aptio Centrifuges, FlexLab High Throughput Centrifuges and FlexLab)
Model Number: 4464-R
Multiple model numbers of affected centrifuges
ARTG Numbers: 174699, 238361 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics is issuing an Urgent Recall for Product Correction Notice for the Hettich centrifuge buckets (Model 4464-R) of affected Hettich Rotanta 46 RSC Robotic and Rotanta 460 Robotic Centrifuges.
Hettich, the centrifuge manufacturer is currently investigating the reason for premature bucket failures. There is the possibility that material changes may have an impact of the strength of the buckets. When the Hettich Centrifuge bucket fails during centrifugation, the potential exists for a delay in patient testing and the potential for movement/rotation of the Centrifuge. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing users with instructions to conduct a weekly check of centrifuge buckets for signs of cracking and replace if required. Additionally, the maximum RPM should be reduced to 3,500 rpm.
This action has been closed out on the 26/10/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |