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

Lot Number 211CO21220

Device Problems Component Missing (2306); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

I received an ihealth covid-19 antigen rapid test kit.Of the two reagent vials, one had nearly no liquid (lot# cvd2121220), and the other had an abrasion or residue on the outside and possibly on the inside as well (lot# cvd2121218).The lot number of the kit was 211co21220 and gtin: (b)(4).Here is a link to a short video showing the problems described: (b)(6).I also informed the company through their online contact form.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 LABS, INC.; 120 san lucar ct.; sunnyvale CA 94086
• MDR Report Key: 13479693
• MDR Text Key: 285458477
• Report Number: MW5107266
• Device Sequence Number: 1
• Product Code: QKP
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 211CO21220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2022
• Patient Sequence Number: 1