MAUDE Adverse Event Report: IHEALTH LABS / ANDON MEDICAL CO., LTD. IHEALTH COVID-19 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number ICO-3000

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2022

Event Type  malfunction  

Event Description

Poor quality text (the letter 'c' on the test strip), pouches with different numbers on the pouches (are they even supposed to have them?) the box was sealed with a clear sticker; i don't know if the tests have been switched out during transit.Test strip has a missing part going through the letter 'c'.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 / ANDON MEDICAL CO., LTD.
• MDR Report Key: 14675297
• MDR Text Key: 294013103
• Report Number: MW5110244
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 20856362005894
• UDI-Public: 20856362005894
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2022
• Device Model Number: ICO-3000
• Device Lot Number: 222CO20127
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1