MAUDE Adverse Event Report: IHEALTH MANUFACTURING INC. IHEALTH COVID-19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number (10): 211CO21229

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

I am having covid-19 symptoms and did a self-test at home which was inconclusive.Waited 12 hours and did a second self-test with the second test kit from the same box as the first kit.Again it was inconclusive.After 3 hours i opened a second box of kits and tested for the 3rd time with the very same results.All kits were from the same manufacturer and have the same lot number.I suspect that they should be recalled as invalid kits.Fda safety report id # (b)(4).

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 15743779
• MDR Text Key: 303236615
• Report Number: MW5113073
• Device Sequence Number: 2
• Product Code: QKP
• UDI-Public: (01):20856362005894
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/02/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/28/2022
• Device Lot Number: (10): 211CO21229
• Patient Sequence Number: 1