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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
Device Problem Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2022
Event Type  malfunction  
Event Description
Both test kits (4 total tests), had no suspension agent in the tubes and the tube were packed with the top already off. Do you have feedback on how many units were manufactured incorrectly? of course, there is no such thing as a "free" test so i am wondering how many how many bad tests we are paying for. 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 Key15328021
MDR Text Key299049343
Report NumberMW5111810
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 08/29/2022
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date07/20/2022
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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