​Cardinal Health—Genius 2 and Genius 3 Tympanic Thermometers: May Not Always Remain within Stated Accuracy Range

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In an October 29, 2019, Urgent Medical Device Correction letter submitted by ECRI Institute member hospitals, Cardinal Health states that the frequency of calibration for the above thermometers as stated in the operating manual may not ensure that the thermometers always remain within the stated accuracy range (±0.2°C for Genius 2 and ±0.3°C for Genius 3). The measurement readings drift upward over time, meaning that the thermometers could exceed the upper stated accuracy tolerance of +0.2°C for Genius 2 or +0.3°C for Genius 3. Cardinal Health also states that the potential patient harms associated with this problem include misdiagnosis and/or delay in treatment; however, the likelihood of harm occurring is low. Cardinal Health further states that it has received no reports of serious injury or harm to patients associated with this problem. The manufacturer has not confirmed the...