FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

CardinalHealth Issues Field Safety Notice for Tympanic Thermometers

Nov. 14, 2019
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CardinalHealth released an urgent field safety notice for its Genius 2 and 3 tympanic thermometers, also known as digital ear thermometers.

The company said the frequency of calibration defined in the devices’ operating manuals may not ensure the thermometers always stay within their stated accuracy ranges, which could delay treatments or lead to misdiagnoses.

“The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance,” Cardinal said.

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