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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANDON MEDICAL CO.,LTD IHEALTH COVID-19 ANTIGEN RAPID TEST

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ANDON MEDICAL CO.,LTD IHEALTH COVID-19 ANTIGEN RAPID TEST Back to Search Results
Model Number ICO-3000
Device Problem Erratic Results (4059)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/29/2022
Event Type  malfunction  
Manufacturer Narrative
Review the production process inspection data and shipping inspection data of the sold products, and the inspection results are in line with the shipping guidelines; ihealth covid-19 antigen rapid test intended use: it is suitable for a single measurement within the first 7 days of the onset of symptoms for people suspected of novel coronavirus. It is also suitable for screening of people without suspected symptoms but suspected of new coronavirus infection or suspected of new coronavirus infection for other epidemiological reasons. Screening can be performed twice within three days, with an interval of 24 to 48 hours. This product cannot be used alone for the diagnosis of new coronavirus infection, and the infection status should be judged in combination with other diagnostic information such as nucleic acid detection and imaging, as well as medical history and contact history. A positive result only indicates the presence of the novel coronavirus n antigen in the sample, and clinical correlation with past medical history and other diagnostic ; based on the detection principle and relevant clinical data, the test results of the ihealth covid-19 antigen rapid test are directly related to the viral load in the sample. When the viral load in the sample is lower than the product's lowest limit of detection (lod), negative results may occur. The samples with lower viral load may be due to the low viral load at the sampling site of the user (the user is asymptomatic or mildly symptomatic), or it may be caused by improper sample collection due to improper operation. It is recommended to judge by continuous detection. Considering that the viral load of users may be different under different disease courses, the results measured by our test kit should be compared with the results of pcr at the same time. For example, some users responded that the results measured by our company's test kit were inconsistent with the pcr results that differed by more than one day. In this case, it may be that the user's own virus infection and virus volume have changed, which cannot be fully proved the kit results are inaccurate.
 
Event Description
Customer feedback: had a probable false positive with the ihealth at home covid test. One person in 4 tested positive. All others continued to test negative for 10 days after as did the person who tested positive in the first place. However all 4 had the same symptoms. How does one person test positive, 3 test negative. But 4 have the same symptoms?.
 
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Brand NameIHEALTH
Type of DeviceCOVID-19 ANTIGEN RAPID TEST
Manufacturer (Section D)
ANDON MEDICAL CO.,LTD
tian jin, airport economic area 30003 08
CH 3000308
Manufacturer (Section G)
ANDON MEDICAL CO.,LTD
tian jin, airport economic area 30030 8
CH 300308
Manufacturer Contact
ren jun
tian jin, airport economic area 30030-8
CH   300308
MDR Report Key13619417
MDR Text Key286925763
Report Number3008573045-2022-00104
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EUA210470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 01/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberICO-3000
Was Device Available for Evaluation? No
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberMW5107115

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