| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00471-1 |
| Product Name/Description |
Alere INRatio2 PT/INR Heparin Insensitive Test Strips
Catalogue Numbers: HS099007EU, HS99007G1, HS099008EU, HS99008G1
All lots within expiry
ARTG Numbers: 162331 and 216755 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
This action is being initiated as a result of post-market surveillance information in the United States (USA), where it has been noted that in rare circumstances patients who return a therapeutic or near therapeutic INR result using the Alere INRatio2 PT/INR Heparin Insensitive Test Strips have had a significantly higher INR (outside of the therapeutic range) when performed within 1 hour to 1 day by a central laboratory. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alere is notifying healthcare providers of an update to the limitations of use for the INRatio 2 PT/INR tests strips. Additionally, consumers are being provided with a Safety Alert notification advising of potential issues with the accuracy of the device and the correct clinical practice with regard to medication dosing. For more details, please see http://www.tga.gov.au/safety/alerts-device-alere-inratio2-140508.htm |
| Contact Information |
07 3363 7711 - Alere Technical Support |