MAUDE Adverse Event Report: IHEALTH MANUFACTURING INC. IHEALTH COVID-19 ANITIGEN RAPID TEST SELF-TEST AT HOME RESULTS IN 15MINS; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number ICO-3000

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

I tried to use ihealth at home rapid antigen tests kits.Two packages with four tests all were assembled incorrectly.The fluid is supposed to be in a separate little plastic pouch to be emptied into the sample collection tube.In these cases the tubes already had a liquid inside.I used the tests anyway and found that the c line on the test card does not appear.I believe these test should be recalled or the equivalent.Gtin (01): (b)(4) / lot no.(10): 221co20130 / use by(17): 2022-07-29.Thank you.Please let me know if you need additional information.(b)(6).Fda safety report id# (b)(4).

• Brand Name: IHEALTH COVID-19 ANITIGEN RAPID TEST SELF-TEST AT HOME RESULTS IN 15MINS
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH MANUFACTURING INC.
• MDR Report Key: 15798765
• MDR Text Key: 304112948
• Report Number: MW5113234
• Device Sequence Number: 2
• 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: 11/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/29/2022
• Device Model Number: ICO-3000
• Device Lot Number: 221CO20130
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White