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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEALGEN SCIENTIFIC LLC /ZHEJIANG ORIENT GENE BIOTECH CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

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HEALGEN SCIENTIFIC LLC /ZHEJIANG ORIENT GENE BIOTECH CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Model Number GCCOV-502A-H5US
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 07/08/2022
Event Type  malfunction  
Event Description
Review of the rapid covid-19 antigen self-test, wanted to perform test as i was known to have come in contact with individuals that tested positive and noticed vial buffer sealed but empty. Therefore instead of a kit of 5 tests it now only has 4. I had to use another test, but the kit is now short one (1) test. Distributed by siemens healthineers. Fda safety report id# (b)(6).
 
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Brand NameCLINITEST RAPID COVID-19 ANTIGEN SELF-TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Manufacturer (Section D)
HEALGEN SCIENTIFIC LLC /ZHEJIANG ORIENT GENE BIOTECH
MDR Report Key15001497
MDR Text Key295905304
Report NumberMW5110804
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 Patient
Type of Report Initial
Report Date 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberGCCOV-502A-H5US
Device Catalogue Number11556712
Device Lot Number2202050EUA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 07/12/2022 Patient Sequence Number: 1
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