| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01239-1 |
| Product Name/Description |
Reflotron Uric Acid (used with Reflotron Plus & Reflotron Sprint Single test chemistry systems) An in vitro diagnostic medical device (IVD)
Material Number: 10745103202
All lot numbers affected
ARTG number: 174909 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
The internal investigation detected deviations in Uric Acid results on the Reflotron system which can be above the internal specification of 5%, if the haematocrit values in whole blood samples exceed 48%. This may lead to erroneously low Uric Acid results in such blood samples. Roche Diagnostics are updating the Product Insert to include the revised limit. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche Diagnostics is advising users to note the haematocrit value limit has been reduced to a maximum of 48%, and advises users to take this into account when measuring patient samples from whole blood.
Roche Diagnostics will be updating the Product Insert as a permanent correction.
This action has been closed on the 17/09/2018 |
| Contact Information |
02 9860 2222 |