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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
Device Problem False Negative Result (1225)
Patient Problems Unspecified Infection (1930); Taste Disorder (4422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Event Description
User left a review comment on (b)(6) website on (b)(6) 2022 that the user trusted this test and she/he had strong symptoms unfortunately so tested twice with this kit 24 hrs apart, a week ago. Both came back negative. He/she went back to work when he/she was feeling better but hadn't quite kicked his/her infection. He/she tested with a unknown different brand the day before (on (b)(6) 2022) from this reporting date and came back positive. He/she went in for pcr test this am, will have results back within 72 hrs but he/she have definitely lost their ability to taste/smell. He/she took another of this test an hour ago, still came back negative. Therefore, the user commented that he/she doesn't trust this test at all and he/she could not find any research link or information regarding this test's positive/negative accuracy stats advertised here. Importer comments: event though, only information that opposite test result from (b)(6) kit and different brand kit exists, this complaint can be a suspected false negative result and due to the system functionality to not allow seller can leave the comments on the website, it is not able for us to follow up to collect additional information, such as product information (lot #, expiration date ect) and any evidence of pcr result to prove false result etc following by reporter's consent.
 
Event Description
User left a review comment on (b)(6) website on (b)(6) 2022 that the user trusted this test and she/he had strong symptoms unfortunately so tested twice with this kit 24 hrs apart, a week ago. Both came back negative. He/she went back to work when he/she was feeling better but hadn't quite kicked his/her infection. He/she tested with a unknown different brand the day before (on (b)(6) 2022) from this reporting date and came back positive. He/she went in for pcr test this am, will have results back within 72 hrs but he/she have definitely lost their ability to taste/smell. He/she took another of this test an hour ago, still came back negative. Therefore, the user commented that he/she doesn't trust this test at all and he/she could not find any research link or information regarding this test's positive/negative accuracy stats advertised here. Importer comments: event though, only information that opposite test result from (b)(6) kit and different brand kit exists, this complaint can be a suspected false negative result and due to the system functionality to not allow seller can leave the comments on the website, it is not able for us to follow up to collect additional information, such as product information (lot #, expiration date ect) and any evidence of pcr result to prove false result etc 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 Key13560353
MDR Text Key285991806
Report Number3008719759-2022-00048
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
Type of Report Initial
Report Date 02/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/27/2022
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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