| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00999-1 |
| Product Name/Description |
Alere INRatio / INRatio 2 PT/INR Monitoring System. An in vitro diagnostic medical device (IVD)
INRatio Prothrombin Time PT Monitoring System
Product Code: HS0100267
INRatio 2 Professional Testing Kit
Product Code: HS0200431
INRatio 2 Home Monitoring Kit
Product Code: HS0200433, HS0200433SJM, HS200433SJMK
INRatio PT/INR Test Strips
Product Codes: HS0100071, HS0100139
INRatio 2 PT/INR Test Strips Heparin-Insensitive
Product Codes: HS99007G1, HS99008G1
ARTG Number: 214252 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
In December 2014 (TGA Ref: RC-2014-RN-01289-1), Alere initiated a correction to inform users of the Alere INRatio System that patients with certain medical conditions should not be tested with the system due to the potential, in certain cases, of the Alere INRatio system to provide an INR result that was significantly lower than a result obtained using a laboratory INR system. Alere has recently decided to remove the Alere INRatio System from the market and to discontinue manufacturing the product line. Alere will continue manufacturing and distributing the Alere INRatio Test Strips for a period of time to allow patients to safely transition to another monitoring method. |
| Recall Action |
Recall |
| Recall Action Instructions |
Alere is advising customers to transition to an alternative method to perform PT/INR testing as soon as possible. Alternate methods may include a plasma-based laboratory INR method or monitoring with a point-of-care system from a different manufacturer. After transitioning onto another system, the Alere system and remaining test strips must be returned to Alere. Customers can continue to use the Alere INRatio System until users have transitioned, as long as patients adhere to the precautions and recommendations found in the 2014 Recall for Product Correction letter and the current product insert.
For further information, please see https://www.tga.gov.au/alert/alere-inratio-ptinr-monitor-system .
This action has been closed out on the 11/10/2018. |
| Contact Information |
1800 622 642 - Alere Technical Support |