MalfunctionSCA
IHEALTH
Received Jun 22, 2026 · Event occurred Jun 14, 2026
Report 3008573045-2026-00006 · MDR key 25573166
Device
Generic name
Multi-analyte Respiratory Virus Antigen Detection Test
Manufacturer
Andon Medical Co.,ltdModel number
ICR-3000Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HOME TEST READ POSITIVE SO I WENT TO THE DOCTOR AND THE TEST WITH THEM WAS NEGATIVE.
Additional Manufacturer Narrative
1. CUSTOMER TESTED POSITIVE USING THE IHEALTH FLU A&B/COVID-19/RSV RAPID TEST, THEN TESTED NEGATIVE AT THE DOCTOR. 2. THE TYPE OF FALSE POSITIVE WAS NOT SPECIFIED. 3. TYPE OF TEST TAKEN AT THE DOCTOR WAS NOT SPECIFIED. 4. LOT NUMBER OF TEST KITS WAS NOT PROVIDED,MANUFACTURER CANNOT EFFECTIVELY VERIFY AND CONFIRM CUSTOMER FEEDBACK.