medical Class II Updated 2020-02-12

Cardinal Health 200, LLC recalls Genius 2 Tympanic Thermometer (discontinued) Item Code: 303

Recalled Product

Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000

Hazard / Issue

The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All product manufactured after October 1, 2016; Serial Numbers greater than or equal to 16598087
View official government recall

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