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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IHEALTH / ANDON MEDICAL CO., LTD. COVID-19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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IHEALTH / ANDON MEDICAL CO., LTD. COVID-19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 223CO20121
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 07/12/2022
Event Type  malfunction  
Event Description
The ihealth covid-19 test did not have a control stripe. The results area remained completely white. It's ridiculous that the expiration date is so soon after the order date. (b)(4), lot no: (10)223co20121 use by (17): 2022-07-20. There should be a better distribution system given how hot it is in (b)(6). Fda safety report id# (b)(4).
 
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Brand NameCOVID-19 HOME TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
IHEALTH / ANDON MEDICAL CO., LTD.
MDR Report Key15027613
MDR Text Key296078676
Report NumberMW5110870
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 07/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/20/2022
Device Lot Number223CO20121
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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