Consumers and health professionals are advised that Alere has issued a safety alert for Alere INRatio2 PT/INR heparin-insensitive test strips due to the potential for incorrect INR results. Alere, in consultation with the TGA, is also undertaking a recall for product correction to update the Instructions for Use (IFU) of test strips that have been supplied to health facilities.
An incorrect INR result could lead to inappropriate dosing with anticoagulants.
The safety alert follows reports in the US of the test strips leading to incorrect results in some groups of seriously ill patients (more details are contained within the Information for Health Professionals section). Alere is notifying health professionals of an update to the IFU. The update includes additional limitations regarding use of the test strips to minimise the potential for this issue to occur.
There have been no reports of serious events due to this issue in Australia.
The affected product catalogue numbers are:
- HS099008EU (supplied to health facilities only)
- HS99008G1 (supplied to health facilities only).
Information for consumers
Please note that this issue is rare and that Alere INRatio2 PT/INR heparin-insensitive test strips that have already been supplied to patients are not being recalled. If you are using these test strips, you can continue to do so, but should be aware of the potential for false readings in some circumstances.
To ensure accurate results, consumers are advised:
- to carefully read and follow all the user instructions and information provided with the product
- the blood drop should always be applied immediately to the test strip
- if you obtain an unusual test result, follow your doctor's recommendation for retesting and do not adjust your medication without consultation
- if the INR result falls within the therapeutic range, but there is reason to believe it could be significantly different (e.g. symptoms such as bleeding or bruising when an INR value is low), arrange testing by an alternative method and consult your doctor
- if you have obtained an unexpected result, experienced other issues related to the use of these test strips or have general questions about the product or user instructions, contact Alere Technical Support on 07 3363 7711 or email email@example.com.
If you have any questions or concerns about this issue, talk to your treating health professional.
Information for all health professionals
Alere has written to health professionals advising them of this issue, including details of the recall for product correction.
Health professionals are advised to be aware of the potential for incorrect INR results being generated under certain circumstances.
In addition to the existing IFU, health professionals should observe the following additional limitations:
- Do not use the Alere INRatio2 PT/INR heparin insensitive test strips on samples from patients with severe coagulopathies such as disseminated intravascular coagulation (DIC) and other conditions associated with rapid changes in coagulation status as occurs in severely ill individuals. Examples of such conditions are severe sepsis, septic shock, and hypotensive shock.
- Do not use the test strips on samples from patients with severe anaemia of any type, which can commonly occur in severely ill patients including those with a history of bleeding.
Not adhering to these updated limitations may result in an inappropriately low INR being reported and patients' coagulation status being misrepresented.
Health professionals are advised that some limitations which were already listed in the Instructions for Use have potentially been factors in the incorrect readings observed in the US:
- Only use the Alere INRatio2 PT/INR heparin-insensitive test strips on patient samples within the labelled haematocrit range of 25% to 53%. Patient samples with a haematocrit below the labelled range, which also have a high INR, may result in a discrepant low INR with the Alere INRatio2 PT/INRP Monitoring System.
- If the INR result falls within the therapeutic range, but there is a reason to believe the INR could be significantly different (e.g., symptoms such as bleeding or bruising when an INR value is low), testing by an alternative method should be immediately arranged.
- When collecting a patient sample, it is important to strictly adhere to proper capillary or venous blood collection techniques as outlined in the IFU. The blood drop should always be applied immediately to the test strip.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.