FDA (Devices) recall action 84202
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Cardinal Health is recalling Genius 2 Tympanic Thermometers because calibration frequency may not ensure readings stay within the stated accuracy range.
Cardinal Health is recalling Genius 2 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.
Cardinal Health is recalling Genius 3 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.
Cardinal Health is recalling Genius 2 tympanic thermometers because readings may drift upward over time, potentially exceeding the stated accuracy range.
Cardinal Health is recalling Genius 2 Tympanic Thermometers because calibration frequency may not ensure readings remain within the stated accuracy range.