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

Catalog Number 20856362005894

Device Problems Labelling, Instructions for Use or Training Problem (1318); Defective Device (2588); Device Ingredient or Reagent Problem (2910); Packaging Problem (3007)

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

Product: ihealth covid-19 antigen rapid test.Gtin(01): (b)(4); lot no.(10): 223co20122.I purchased two of these kits in (b)(6) maybe a year ago and tried to use them yesterday.I found three manufacturing defects in both kits.The vials contained no fluid or reagent - they were empty.The labels on the vial had a sticky backing but were not fully adhered to the file - they were not wrapped around but just hanging loosely.The swab was packaged so that the tip of the swab was positioned at the "open here" end of the package - meaning you extracted the swab by pulling on the tip, not the stem.I also had purchased (i think at the same place and time) the product with lot no.211c21215 which had none of these defects and worked fine.Ref report: mw5118366.

• Brand Name: IHEALTH COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC. / IHEALTH MANUFACTURING INC.
• MDR Report Key: 17125737
• MDR Text Key: 317220775
• Report Number: MW5118367
• 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: 06/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/21/2022
• Device Catalogue Number: 20856362005894
• Device Lot Number: 223CO20122
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White