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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IHEALTH LABS, INC. IHEALTH AT HOME RAPID ANTIGEN COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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IHEALTH LABS, INC. IHEALTH AT HOME RAPID ANTIGEN COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/22/2022
Event Type  malfunction  
Event Description
Had a probable false positive with the ihealth at home covid test. One person in 4 tested positive. All others continued to test negative for 10 days after as did the person who tested positive in the first place. However all 4 had the same symptoms. How does one person test positive, 3 test negative, but 4 have the same symptoms? fda safety report (b)(4).
 
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Brand NameIHEALTH AT HOME RAPID ANTIGEN COVID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
IHEALTH LABS, INC.
120 san lucar ct
sunnyvale CA 94086
MDR Report Key13424101
MDR Text Key285072401
Report NumberMW5107115
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 01/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 02/01/2022 Patient Sequence Number: 1
Treatment
MELATONIN; NASONEX
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