EMBRACE TALK TEST STRIPS
Received Nov 13, 2024 · Event occurred Nov 10, 2024
Report MW5162515 · MDR key 20686957
Device
Generic name
System, Test, Blood Glucose, Over The Counter
Manufacturer
Omni/ Apex Biotechnology Corp.Lot number
(10)THS2402005
Patient
86 YR · Prefer Not To Disclose
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
RECEIVED EMBRACE TALK GLUCOSE TESTING STRIPS IN MAIL IN OCTOBER 2025. TEST STRIP BOX APPEARS TO HAVE BEEN TAMPERED WITH; (B)(4), EXP: (17)2026-02-01; LOT: (10)THS2402005. BOX HAD TAPE ON TOP WHEN RECEIVED; I OPENED IT TO FIND THE CANISTER OF STRIPS WAS OPEN, MULTIPLE SMALL BEIGE COLORED BEADS FELL OUT OF PACKAGE. PRESCRIPTION FOR TEST STRIPS WERE SENT FROM (B)(4); THIS IS A MEDICARE BENEFIT. I AM RETAINING THE BOX AND THE CONTENTS; SOME BEADS WERE DISCARDED. I WILL ALSO NOTIFY ADAPT. PHOTO SHOWS BOX WITH LOT; SMALL BEIGE BEADS, OPENED CANISTER. I WOULD LIKE A RESPONSE REGARDING THIS PRODUCT.