| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00112-1 |
| Product Name/Description |
Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitative measurement of haemoglobin in venous blood samples
Material Number: 10744964202
All lot numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diagnostics has confirmed that there is an increase in imprecision leading to higher results of the haemoglobin (Hb) measurement when using capillary samples on the Reflotron Systems. Testing with venous samples is not affected by this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The use of capillary blood samples with Reflotron is no longer recommended. The package insert will be amended to reflect this change. It is recommended that the recall letter is retained with the Reflotron Hb test strips until the package insert has been updated. |
| Contact Information |
1800 645 619 - Roche National Support Centre |