medical Class II Updated 2020-02-12

Cardinal Health 200, LLC recalls Genius 2 Tympanic Thermometer Private Label Item Code: 30

Recalled Product

Genius 2 Tympanic Thermometer Private Label Item Code: 3069


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 N16601357
View official government recall

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