Safety Alerts & Recalls

What does this mean?

Abbott is providing free software updates. If your FreeStye InsuLinx meter is registered, Abbott will contact you directly to update your meter. You can also go to the Abbott Diabetes Care webpage for step by step information on how to update your meter: http://www.freestyleinsulinx.com/swupdate

You may continue to use your meter until it is updated. The new software will not affect any history that your meter holds.

For any concerns please contact your health care professional. Abbott can also be contacted on 1800 639 505 between 8am and 5pm (AEST), Monday to Friday. Please note that the FreeStyle InsuLinx is the only meter that is affected - all other models are unaffected.

Freestyle Insulinx Glucose Meters Recalled After Fault Found

Abbott Diabetes Care has begun a recall to correct a fault in the FreeStyle InsuLinx Blood Glucose Meter. A software update is required to correct incorrect blood glucose readings in measurements over 56.8mmol/L.

The meter will read 56.8mmol/L less than the actual reading in the rare instance of a reading being higher than 56.8mmolL. For example a reading of 60mmol/l would read as 3.2mmol/L. The problem can be corrected with a software update of the meter.

The likelihood of a reading being this high is unlikely however is medically significant and would require immediate medical attention to minimise the damage of significantly high blood sugar levels on the body.

Continued use of the meter without an update does pose a risk of delayed knowledge of having a high blood sugar reading.

For more information, please visit: more information here

Source: TGA
Publication Date: 2013-04-22
Last Updated: 2013-04-22
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