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Urgent Medical Device Correction: OneTouch® Ultra®, OneTouch® FastTake®, InDuo®, EuroFlash®, SmartScan®, and PocketScan® Meters

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-- OneTouch® Ultra®, OneTouch® FastTake®, InDuo®, EuroFlash®, SmartScan®, and PocketScan® Meters --

April 12, 2005

If you use, recommend, distribute or sell the OneTouch®Ultra®, OneTouch® FastTake®, InDuo®, EuroFlash®, SmartScan®, or PocketScan® Meter, we want you to be aware of two possible issues regarding these products.

1. These meters are designed to show results in two different units of measure. When setting a meter's date and time, it is possible for the user to accidentally change the unit of measure. Blood glucose results could be misinterpreted if the meter is set to the wrong unit of measure.

2. Very rarely, an event such as dropping a meter while in use can cause a brief power loss. As a result, the meter may unexpectedly change the units of measure and/or the code number.

To find out how these issues may affect you, or your patients, it is important to know which unit of measure has been adopted by the country in which you live. Please read one of the notices based on the unit of measure used in your country.

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