ORAL THERMOMETER

Description of Event or Problem

PRODUCT: ORAL DIGITAL THERMOMETER MODEL NUMBER: KD-1770 LOT NUMBER: 2502. ON (B)(6) 2025, I DISCOVERED THAT THIS OVER-THE-COUNTER MEDICAL DEVICE IS DANGEROUSLY INACCURATE AND POSES A SIGNIFICANT PUBLIC HEALTH RISK. OVER THE COURSE OF MORE THAN 30 SEPARATE TESTS, PERFORMED UNDER CONSISTENT AND PROPER USAGE CONDITIONS, THE THERMOMETER HAS PRODUCED WILDLY VARIANT RESULTS WITH A TOTAL SPREAD OF 2.4 DEGREES FAHRENHEIT. I HAVE PHOTOGRAPHIC DOCUMENTATION OF THESE INCONSISTENT READINGS. THE ACCEPTED CLINICAL STANDARD FOR THIS TYPE OF MEDICAL DEVICE (PER ASTM E1112) IS AN ACCURACY OF ±0.2°F. THIS PRODUCT EXHIBITS AN ERROR RANGE THAT IS SIX TIMES THE MAXIMUM ALLOWABLE VARIANCE, RENDERING IT COMPLETELY UNRELIABLE FOR ITS INTENDED MEDICAL PURPOSE OF ASSESSING BODY TEMPERATURE. THIS LEVEL OF INACCURACY PRESENTS A DANGER TO ANY CONSUMER. A FALSE LOW READING COULD CAUSE AN INDIVIDUAL WITH A FEVER TO DELAY SEEKING CRITICAL MEDICAL CARE. CONVERSELY, A FALSE HIGH READING COULD CAUSE UNNECESSARY PANIC AND MEDICAL VISITS. GIVEN THAT THIS IS A WIDELY AVAILABLE CONSUMER MEDICAL DEVICE SOLD UNDER THE CVS BRAND, THIS DEFECT REPRESENTS A SIGNIFICANT AND IMMEDIATE SAFETY LIABILITY.