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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUMASIS CO., LTD. DIATRUSTTM COVID-19 AG HOMETEST; IN VITRO DIAGNOSTICS
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HUMASIS CO., LTD. DIATRUSTTM COVID-19 AG HOMETEST; IN VITRO DIAGNOSTICS Back to Search Results
Device Problem False Negative Result (1225)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
On december 22, 2023, celltrion usa received an email with complaint of false negative.The user emailed that the covid test with diatrust was false negative because the user tested positive at the dr office.Importer comments: celltrion usa is currently acting as an importer and distributor of the 'celltrion diatrust covid-19 diagnostic test kit', which was approved under eua by usfda in 2020.Until now, celltrion has been reported emdrs to the us fda using the manufacturer's fei#, but the fei# was recently changed to invalid.Therefore, celltrion cannot immediately report this mdr until this issue is solved.Accordingly, celltrion will report mdr through a voluntary reporting process instead of a mandatory reporting process to show its commitment to reporting.This report is the initial case reported by the user.If we get receive additional information from the user, we will report to fda.
 
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Brand Name
DIATRUSTTM COVID-19 AG HOMETEST
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 Key18753935
MDR Text Key335935842
Report Number3015423092-2024-00001
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 02/21/2024
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 Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/22/2023
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/21/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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