The company said in the Oct. 30 notice that all Genius 2 tympanic thermometers manufactured after Oct. 1, 2016 were affected, along with all Genius 3 tympanic thermometers manufactured after Dec. 4, 2017. The Genius 2 has also been discontinued.
According to the notice, the Genius devices’ frequency of calibration as stated in the operating manual may not ensure that the thermometers remain within the stated accuracy range, which is ± 0.2°C for Genius 2 and ± 0.3°C for Genius 3 thermometers.
Cardinal Health said the measurement readings go up over time, meaning the thermometers could exceed the accuracy tolerance of +0.2°C for Genius 2 or +0.3°C for Genius 3, which could result in misdiagnosis and/or delay in treatment.
The company added that the likelihood of harm is low and there have been no reports of serious injury or harm to patients. Cardinal Health said it is updating the operating manual to require thermometers to be calibrated at an increased frequency.
Cardinal Health suggested that users of the Genius thermometers inspect inventory for affected devices and calibrate all those affected. After calibration, users are urged to contact Cardinal Health to schedule a software update on the device, then recalibrate all thermometers again.
A Cardinal Health spokesperson could not be immediately reached for comment.