MAUDE Adverse Event Report: IHEALTH LABS COVID TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 221C020127

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

I have a ihealth covid-19 antigen rapid test kit.The expiration date on the box is 2022-07-26 (now expired.However, the viles in the box have an expiration date of 2024-01-16.Why are they different? which date should i go with? fda safety report id # (b)(4).

• Brand Name: COVID TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS; 150c charcot ave; san jose CA 95131
• MDR Report Key: 15265446
• MDR Text Key: 298396645
• Report Number: MW5111607
• 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: 08/17/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 221C020127
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White