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U.S. Department of Health and Human Services

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

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IHEALTH LABS, INC. COVID RAPID ANTIGEN TEST KIT AT HOME CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Model Number GIN(01): 20856362005894
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/29/2022
Event Type  malfunction  
Event Description
Tested for covid using ihealth home test kit given out by (b)(6) while experiencing severe symptoms of flu like symptoms. Result came negative. Next day did rtpcr test that came positive. Used the home test kit again to verify reliability. False negative again. Inadvertently exposed many people to covid due to false negative. Poor quality unreliable product. Test kit supplied by (b)(6). Imported from (b)(6). Gin (b)(4) lot no. (10): 213c021224 -06 use by(17): 2022-06-23. Fda safety report id # (b)(4).
 
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Brand NameCOVID RAPID ANTIGEN TEST KIT AT HOME
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Manufacturer (Section D)
IHEALTH LABS, INC.
120 san lucar ct.
sunnyvale, CA 94086
MDR Report Key13426298
MDR Text Key285223623
Report NumberMW5107161
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
Type of Report Initial
Report Date 01/31/2022
2 Devices were Involved in the Event: 1   2  
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
Device Operator
Device Expiration Date06/23/2022
Device Model NumberGIN(01): 20856362005894
Device Catalogue Number20856362005894
Device Lot Number(10): 213C021224-06
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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