Recall Z-0991-2020 ยท FLL Continuous Measurement Thermometer
Cardinal Health 200, LLC
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
| Date | Oct 28, 2019 |
| Status | Terminated |
| 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 ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3. |
| Root cause | Under Investigation by firm |
| Action | Cardinal Health issued Correction Notice and Acknowledgement Form via overnight on October 28, 2019 to the direct consignees. The Medical Device Correction Notice provides instructions to our direct consignees to notify any customers who they may have further distributed affected product as to the market action. Letter states reason for recall, health risk and action to take: Customers are instructed that if they have access to a Genius Checker/Calibrator to calibrate all affected Genius thermometers. Following calibration, customers are to contact Cardinal Health Service & Repair to schedul |
| Quantity | 7425 US; OUS 214278 |
| Distribution | Worldwide Distribution - US Nationwide and Foreign in the countries of: Australia Austria Belgium Canada Canary Islands Chile Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana French Polynesia Gabon Germany Gibraltar Greece Guadeloupe Hong Kong Iran, Islamic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060649 | GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 Tyco Healthcare Group LP, May 22, 2006 |