MAUDE Adverse Event Report: IHEALTH LABS / IHEALTH MANUFACTURING INC. IHEALTH COVID-19 ANTIGEN RAPID TEST ICO-3000; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 222CO20214

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

There was not enough solution provided to fill the tube up to "edge 2" (test set 2).Instructions say to discard the test in this case.I have discarded 4 tests for this reason and had to find a different brand.Seems like a manufacturing defect.These are tests the us government mailed to me.Waste of money.Ihealth covid-19 antigen rapid test (orange and white box) gtin(01): (b)(4), lot no.(10):222co20214 use by(17): (b)(6) 2022 extended to (b)(6) 2023.

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST ICO-3000
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS / IHEALTH MANUFACTURING INC.
• MDR Report Key: 16214542
• MDR Text Key: 307931597
• Report Number: MW5114389
• Device Sequence Number: 2
• 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: 01/17/2013
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 222CO20214
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2023
• Patient Sequence Number: 1