Recall Z-0991-2020— Cardinal Health 200, LLC

Name: FDA recall Z-0991-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-28

Class II · Terminated

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2019-10-28, terminated 2022-05-17. It names one FDA 510(k) clearance: K060649. Product: Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013. Reason: 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..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-10-28
Terminated: 2022-05-17
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K060649 — GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000Tyco Healthcare Group LP·cleared 2006-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.