Medium RiskFDA Device

Cardinal Health 200, LLC: 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.

Agency Publication Date: February 4, 2020

Affected Products

Product: Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000

All product manufactured after October 1, 2016; Serial Numbers greater than or equal to 16598087

Product: Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013

All product manufactured after December 4, 2017; Serial Numbers greater than or equal to N17700101

Product: Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062

All product manufactured after October 1, 2016; Serial Numbers greater than or equal 16597907

Product: Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063

All product manufactured after December 10, 2017; Serial Numbers greater than or equal to N17606406

Product: Genius 2 Tympanic Thermometer Private Label Item Code: 3069

All product manufactured after October 1, 2016; Serial Numbers greater than N16601357

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84202

Status: Resolved

Manufacturer: Cardinal Health 200, LLC

Manufactured In: United States

Units Affected: 5 products (30142 US; OUS 113841; 7425 US; OUS 214278; 3619 OUS; in total 37567 units US; 335573 OUS; in total 37567 units US; 335573 OUS)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products