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U.S. Department of Health and Human Services

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

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IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Ordered two cases of 180 ihealth covid-19 antigen tests from sunline supply for use by our theatre employees. Our covid compliance officer reported that 45% of the tests from sunline supply came out blank, with no control line, and many had reagent tubes that were empty. Fda safety report id# (b)(4).
 
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Brand NameIHEALTH COVID-19 ANTIGEN TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
IHEALTH LABS, INC.
MDR Report Key14694900
MDR Text Key294130871
Report NumberMW5110301
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 06/11/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2022
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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