Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0992-2020 — Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062

U.S. FDA — Device Enforcement · United States · 2019-10-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0992-2020
Date of alert
2019-10-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cardinal Health 200, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
16597907
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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