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

Lot Number 223CO20214

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 07/24/2022

Event Type  malfunction  

Event Description

Recently requested a batch of free covid tests from fda, received 4 boxes of ihealth covid-19 antigen rapid test, lot number 223co20214.Each tests comes with an empty collection tube and a sealed solution ampule.According to instructions, solution must reach at least first line in collection tube when filled, however ampule only contains enough solution to fill roughly half-way to line.Don't know if these tests were sent with inadequate amounts of solution, or if instructions are wrong, and only half as much solution is needed.Should i throw tests out? use them as with half solution? can i get extra solution or replacement tests, or am i out of luck? 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, INC.; 150c charcot ave; san jose CA 95131
• MDR Report Key: 15112691
• MDR Text Key: 296769168
• Report Number: MW5111123
• 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: 07/24/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/13/2022
• Device Lot Number: 223CO20214
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White