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

Device Problems Device Markings/Labelling Problem (2911); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2022

Event Type  malfunction  

Event Description

We have noticed more than 6 boxes of our ihealth covid antigen tests have been faulty.All of them are dated 2022-06-27 expirations.They do not seem to produce adequate control or test lines (control most of the time being the issue) when used correctly.Fda safety report id# (b)(4).

• Brand Name: IHEALTH ANTIGEN COVID 19 AT HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave; san jose CA 95131
• MDR Report Key: 15241035
• MDR Text Key: 298203990
• Report Number: MW5111497
• Device Sequence Number: 5
• 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: 08/13/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/27/2022
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White