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Further to the information published in the below alert, more details of the recall of the Alere INRatio PT/INR monitor system are now available.
Alere INRatio and Alere INRatio 2 PT/INR monitors, as well as the INRatio Test Strips that are used with these monitors, are being withdrawn from the market.
However, Alere will continue manufacturing and distribution of the test strips for a period of time to allow patients to safely transition to another monitoring method.
It is recommended that patients consult with their health professional as soon as possible to begin transition to an alternate method of PT/INR testing.
Until then, patients should continue to use their Alere INRatio PT/INR monitor system, but note that incorrect results can occur if they have certain medical conditions (see 'Information for health professionals' below for further details) or if instructions provided in the labelling for the device are not followed.
Alere has written to affected patients and health professionals providing further information about this issue, including details of the recall procedure. Alere also recommends that all patients have periodic verification of their INR using a laboratory INR method as soon as possible. The patient’s anticoagulation therapy may then need adjustment.
If you have any questions or concerns, speak to your health professional or contact Alere on 07 3363 7711 or 1800 622 642.
Update - Recall
21 July 2016
Consumers and health professionals are advised that Alere, in consultation with the TGA, will be recalling the Alere INRatio PT/INR monitor system.
Measures taken by Alere to address the potential for the device to provide an incorrect INR result, including software improvements and changes to the Instructions for Use, have not adequately mitigated the identified risks (see previous statement below). Based on this, and Alere's business considerations, this device is being withdrawn from the market.
The TGA is working with Alere on developing the recall strategy, including communication to affected patients and health professionals on safely transitioning to an alternate testing method.
Further information regarding this matter will be published as soon as it becomes available.
In the meantime, patients should talk to their health professional before making any changes to their anticoagulation monitoring, or if they have any other questions or concerns about this issue.
Recall for product correction - potential for incorrect INR results
15 December 2014
Consumers and health professionals are advised that Alere, in consultation with the TGA, has initiated a recall for product correction for its Alere INRatio PT/INR monitor system.
Alere INRatio PT/INR monitor systems comprise an INRatio or INRatio 2 monitor and INRatio or INRatio 2 test strips. They are used by health professionals and for self-testing by patients who are taking anticoagulant medicines, sometimes referred to as 'blood-thinners', such as warfarin.
It has been identified that, in certain cases, Alere INRatio PT/INR monitoring systems may provide an incorrect INR result that is clinically significantly lower than what it would be if obtained using a laboratory INR method.
This can occur if the patient has certain medical conditions (details of the specific medical conditions are available in the 'Information for health professionals' section below) or if instructions provided in the labelling for the device are not followed.
If an incorrectly low INR result is received, it could lead to a delay in taking action to reverse a high INR level or, in the worst case scenario, no action to reverse a high INR level being taken.
The TGA and Alere are continuing to investigate this issue. In the meantime Alere is undertaking a recall for product correction to update the Instructions for Use for Alere INRatio PT/INR monitor systems. The update provides instructions on how to minimise the risks associated with the above issue, including information about the conditions under which Alere INRatio PT/INR monitor systems should not be used.
Related information was provided in a safety alert published on the TGA website on 8 May 2014.
The affected products are:
| Product | Ref number | Product description |
|---|---|---|
| INRatio test strips | HS0100071 | Alere INRatio PT/INR test strips, box of 12 |
| HS0100139 | Alere INRatio PT/INR test strips, box of 48 | |
| HS099007EU | Alere INRatio 2 PT/INR test strips, box of 12 | |
| HS99007G1 | Alere INRatio 2 PT/INR test strips, box of 12 | |
| HS099008EU | Alere INRatio 2 PT/INR test strips, box of 48 | |
| HS99008G1 | Alere INRatio 2 PT/INR test strips, box of 48 | |
| INRatio monitors | HS0100267 | INRatio PT monitoring system |
| INRatio 2 monitors | HS0200431 | Alere INRatio 2 PT/INR professional monitoring system |
| HS200433SJM | Alere INRatio 2 PT/INR home testing system | |
| HS200433SJMK | Alere INRatio 2 PT/INR home testing system | |
| HS0200433 | Alere INRatio 2 PT/INR home testing system |
Information for consumers
Alere has written to health professionals and provided further information about this issue.
If you, or someone you care for, have an Alere INRatio PT/INR monitoring system, talk to your health professional to undertake additional testing and confirm that using this device is still appropriate for you to use for self-testing.
Do not change your anticoagulant medicine or dose without consulting with your health professional.
Follow the instructions provided in the labelling for your device, including applying only one large drop of blood immediately to the test strip. Never add more blood to a test strip after the test has begun.
If you have any doubts about an INR result received, repeat the test with a fresh test strip and a fresh drop of blood from a new finger-prick site using a new lancet.
The monitor should be a on a stable surface and you should not move the monitor during the test.
If you follow these instructions and still have doubts about an INR result, or you have any questions or concerns about this issue, speak to your health professional.
Information for all health professionals
If you are treating a patient who uses an Alere INRatio PT/INR monitor system, consider if using this device is still appropriate for them.
Alere INRatio PT/INR monitor systems should not be used in patients with any of the following conditions:
- anaemia of any type with haematocrit less than 30% for Alere INRatio PT/INR test strips, or less than 25% for Alere INRatio 2 PT/INR test strips (heparin insensitive)
- any conditions associated with elevated fibrinogen levels, including:
- acute inflammatory conditions (examples may include acute viral or bacterial infections such as pneumonia or influenza)
- chronic inflammatory conditions (examples may include rheumatoid arthritis, Crohn's disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis)
- severe infection (for example sepsis)
- chronically elevated fibrinogen for any reason
- hospitalised or advanced stage cancer or end stage renal disease patients requiring haemodialysis
- any bleeding or unusual bruising, either clinically observed or reported by the patient.
Patients with any of the conditions listed above who are being tested with an Alere INRatio PT/INR monitor system should immediately be transitioned to a suitable alternative monitoring device or laboratory INR method for testing.
Only patients who have already been stabilised on their anticoagulant medicine should be tested with the Alere INRatio PT/INR monitor system.
If the Alere INRatio PT/INR monitor system's INR result falls within the therapeutic range, but there is reason to believe the INR may be significantly different (for example symptoms such as bleeding or bruising that suggest the INR value may be incorrectly low), testing by an alternative method should be performed immediately.
Be aware that the actual value of a supratherapeutic INR result could be higher than the value as measured by device.
Only use the Alere INRatio PT/INR monitor system on patient samples within the haematocrit range 30% to 55% for Alere INRatio PT/INR test strips, or 25% to 53% for the Alere INRatio 2 PT/INR test strips (heparin insensitive).
In addition to the above, it is recommended that you arrange for patients who use the Alere INRatio PT/INR monitor system to have periodic verification of their INR using a laboratory INR method. Any patient who is receiving a significant incorrectly low result on their Alere INRatio PT/INR monitor system, as compared to the laboratory INR method, should immediately be transitioned to an alternative method for testing.
It is also recommended that you arrange to have your patients tested to verify that their haematocrit fall within the range of 30% to 55% for Alere INRatio PT/INR test strips, or 25% to 53% for the Alere INRatio 2 PT/INR test strips (heparin insensitive). Patients with haematocrit outside this range should be immediately transitioned to a laboratory INR monitoring method.
If you have any questions or concerns about this issue, contact Alere on 07 3363 7711 or 1800 622 642.
Reporting problems
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.