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U.S. Department of Health and Human Services

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

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IHEALTH LABS, INC. COVID-19 ANTIGEN RAPID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Lot Number (10)221CO20214
Device Problem Material Discolored (1170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2022
Event Type  malfunction  
Event Description
I opened an ihealth covid-19 testing kit and found that the nasal swab had a discolored dot on the swab. I haven't used or opened the swab and got another test kit to complete my testing. Fda safety report id # (b)(4).
 
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Brand NameCOVID-19 ANTIGEN RAPID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Manufacturer (Section D)
IHEALTH LABS, INC.
150c charcot ave
san jose CA 95131
MDR Report Key14874323
MDR Text Key295126297
Report NumberMW5110609
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 06/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/12/2022
Device Lot Number(10)221CO20214
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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