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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CELLTRION USA INC. CELLTRION DIATRUST COVID 19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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CELLTRION USA INC. CELLTRION DIATRUST COVID 19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number COVGCA 1005
Device Problem False Negative Result (1225)
Patient Problem Viral Infection (2248)
Event Date 09/14/2022
Event Type  malfunction  
Event Description
[celltrion diatrust ] use for covid-19 under emergency use authorization (eua): covid 19 antigen test lot covgca 1005 expiration date nov 2, 2022 is generating false negative results at 15 minutes read time, as per insert.Initially detected faint positive result after 1 hour (insert indicates read time 15 minutes).Subsequent patients tested positive on home testing devices, results were negative on celltrion diatrust kit, indicated test kit.Sample was retested on alternate covid 19 antigen kit (allere binax now) obtained positive results as per package insert.Binax now from allere coincides with patient result obtained on home test kit.Fda safety report id# (b)(4).
 
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Brand Name
CELLTRION DIATRUST COVID 19 ANTIGEN TEST
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
CELLTRION USA INC.
1 evertrust plaza ste 1207
jersey city NJ 07302
MDR Report Key15437843
MDR Text Key300225691
Report NumberMW5112071
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2022
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 Health Professional
Device Expiration Date11/02/2022
Device Lot NumberCOVGCA 1005
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/15/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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