Reported Feb 12, 2020 · Terminated
Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
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 2 Tympanic
- Thermometer OEM Tympanic Item Code303063
- Lot codes and dates
- All product manufactured after December 10, 2017; Serial Numbers greater than or equal to N17606406
- Amount recalled
- in total 37567 units US; 335573 OUS
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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