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

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Event Description

I have a box of 5 ihealth covid-19 antigen rapid tests.The issue is that the expiration on the box states 05/08/2023 for lot 221co20509.The page that lists ihealth test extensions shows a use by date of 02/08/2023 for that lot number (from link https://www.Fda.Gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list).It lists a new use by date of 08/08/2023 for that specific lot number.My question is that the expiration dates on the kit 05/08/2023 and on the page 02/08/2023 are different so is the extension to 08/08/23 still valid? also, the expiration date on the vials of reagent from that box is 12/16/2023 for reagent lot cvd2121220.Reference reports: mw5118307, mw5118308, mw5118310, & mw5118311.

• 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: 17107195
• MDR Text Key: 317056057
• Report Number: MW5118309
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White