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

Lot Number 223CO20121

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 12/30/2022

Event Type  malfunction  

Event Description

I ordered free covid-19 home test kits that were offered beginning december 2022.I received them today, and they expired july 20, 2022.I checked to see if the expiration dates have been extended, and they were.According to the manufacturer and lot number, it has been extended to january 20, 2023.Why would you even bother to spend the money to send kits that expire 3 weeks after receipt, they are all but worthless to us.The manufacturer is ihealth, lot number 223co20121.It's fortunate that our local library is handing out free test kits.The expiration date on those is in only about 3-4 months, which limits their usefulness, but i can keep returning to get more when needed.

• Brand Name: COVID-19 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 16102986
• MDR Text Key: 306799153
• Report Number: MW5114157
• 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: 12/30/2022

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 Expiration Date: 07/20/2022
• Device Lot Number: 223CO20121
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2023
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White