KETONE

Additional Manufacturer Narrative

INTERNAL REPORT REFERENCE NUMBER: (B)(4). KETONE TEST STRIPS WERE RETURNED - LOT NUMBER IS UNREADABLE, UNABLE TO READ/VERIFY LOT NUMBER (RUBBED OFF). RETURN PRODUCT SCRAPPED. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-001: USER HAD AN INACCURATE REFERENCE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 03-JUN-2025 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

Description of Event or Problem

CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS KETONE TEST STRIPS OF NEGATIVE/NO CHANGE TRACE RESULTS. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER WAS CONTACTED BY TELEPHONE. CUSTOMER STATED HE BEGAN USING THE KETONE TEST STRIPS BACK AT THE END OF MARCH, AND TO DATE THERE HAS BEEN NO CHANGE TO THE COLOR OF THE STRIPS WHEN URINE IS APPLIED. CUSTOMER STATED THAT HE HAS BEEN CONSISTENTLY LOSING WEIGHT WHICH IS WHY HE BELIEVED THE PRODUCT TO BE DEFECTIVE. CUSTOMER WAS UNABLE TO SEE THE LOT NUMBER FROM THE KETONE STRIPS BUT ADVISED THAT THEY ARE THE TRUEPLUS KETONE STRIPS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM AND THE CUSTOMER IS USING PROPER TESTING TECHNIQUE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. CUSTOMER DECLINED TO PERFORM A TEST DURING THE CALL.