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

Model Number ICO-3000

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

Patient Problem Insufficient Information (4580)

Event Date 12/23/2022

Event Type  malfunction  

Event Description

Ihealth covid-19 rapid antigen test with fda eua and shelf life extension possibly not lasting the full duration of modified expiration date.From this update: https://www.Fda.Gov/media/158007/download, i used a test in lot number 211co21229 but test is invalid and no control line appearing.Should still not be expired.

• Brand Name: IHEALTH COVID-19 RAPID ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC. /IHEALTH MANUFACTURING INC.
• MDR Report Key: 16067478
• MDR Text Key: 306341446
• Report Number: MW5114039
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 20856362005894
• UDI-Public: (01)20856362005894
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/23/2022

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 Operator: Lay User/Patient
• Device Expiration Date: 06/28/2022
• Device Model Number: ICO-3000
• Device Lot Number: 211CO21229-05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2022
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Race: Asian