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U.S. Department of Health and Human Services

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

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HUMASIS CO., LTD. CELLTRION DIATRUST COVID-19 AG HOME TEST IN VITRO DIAGNOSTICS Back to Search Results
Model Number CT-P60 D-2 05
Device Problems False Negative Result (1225); Computer System Security Problem (2899)
Patient Problem Viral Infection (2248)
Event Type  malfunction  
Event Description
On march 8, 2022, a user reported product complaints about the product to amazon customer service center, and the staff sent an email to celltrion. Asin : b09m7gkccb, upc : 8806121763235, model # :ct-p60 d-2 05. User said that all four tests came back negative despite a rapid antigen test being positive at urgent care. Unfortunately, she trusted this test and she had strong symptoms, and she tested twice with this kit 24 hrs apart, a week ago. Both came back negative. When she felt better she started working again but hadn't quite kicked the infection. She tested with a different brand yesterday and came back positive. When she scanned the test device's qr code as per instructions, it said "problem serial number" this is not a valid covid-19 ag home test did 2 tests and both negative. 2nd test was done same day as pcr which came back positive. Importer comments: this is a phenomenon that occurs because the serial number of the product and the application for activation are not synchronized. There is no error with the diagnosis of covid-19 but activation of the application through qr code is part of the product's functionality so that we assessed this is in criteria of 'malfunction' according to the 21cfr803. 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, such as product information (lot #, expiration date etc. ) and any further information to investigate the type of complaint following by reporter's consent.
 
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Brand NameCELLTRION DIATRUST COVID-19 AG HOME TEST
Type of DeviceIN VITRO DIAGNOSTICS
Manufacturer (Section D)
HUMASIS CO., LTD.
88, jeonpa-ro
dongan-gu
anyang-si, gyeonggi-do 14042
KS 14042
MDR Report Key13906027
MDR Text Key295250307
Report Number3008719759-2022-00055
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 03/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCT-P60 D-2 05
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/08/2022
Event Location Home
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

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