Reported Feb 12, 2020 · Terminated
Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 15 Hampshire St Bldg 5 · Mansfield, MA · 02048-1113
Is this the product you have?
- Genius 3 Tympanic Thermometer-
- electric thermometer Item Code303013
- Lot codes and dates
- All product manufactured after December 4, 2017; Serial Numbers greater than or equal to N17700101
- Amount recalled
- 7425 US; OUS 214278
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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