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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUMASIS CO., LTD. DIATRUSTTM COVID-19 AG HOME TEST; IN VITRO DIAGNOSTICS

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HUMASIS CO., LTD. DIATRUSTTM COVID-19 AG HOME TEST; IN VITRO DIAGNOSTICS Back to Search Results
Device Problems False Negative Result (1225); Lack of Effect (4065)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
On october 16, an amazon customer commented that the product was false negative: a customer bought this to fill out a free service provided by the government, and said it was not effective and more difficult to use.The user has guessed that this is probably a lot of false negatives and it doesn't seem to work with the omnicron variant.Importer comments: due to the system functionality to not allow seller can leave the comments on the website or contact the reporter, it is not able for us to follow up to collect additional information and such as product information (lot #, expiration date, etc.) following by reporter's consent.
 
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Brand Name
DIATRUSTTM COVID-19 AG HOME TEST
Type of Device
IN VITRO DIAGNOSTICS
Manufacturer (Section D)
HUMASIS CO., LTD.
88, jeonpa-ro
dongan-gu
anyang-si, gyeonggi-do 14042
KS  14042
MDR Report Key15680284
MDR Text Key302594647
Report Number3008719759-2022-00143
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 Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/16/2022
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/27/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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