| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00415-1 |
| Product Name/Description |
CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD)
Material numbers: 04796179001, 04811500001, 04963733001, 06505597001, 04800842190, 05864640001, 06505589001, 06644511001, 05530199190 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Roche has discovered that in rare cases (<0.00015%) an “ERROR 6” may also be displayed by individuals who are under treatment with warfarin in combination with antibiotics and/or chemotherapeutics. In such patients INR values could be extremely high (>10 INR). The CoaguChek displays the various codes when it suspects there could be a problem with the actual measurement of your INR. "ERROR 6” when shown in the display represents alerts to a number of issues with the testing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In the event of an "error 6" end users are advised to repeat the test and if the error continues contact their physician immediately. The package insert for the CoaguChek XS PT strips will be updated to contain this information. For more information, please see http://www.tga.gov.au/safety/alerts-device-coaguchek-inr-monitors-130516.htm . |
| Contact Information |
1800 645 619 - Roche Diagnostics Technical Support |