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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANDON MEDICAL CO.,LTD IHEALTH COVID-19 ANTIGEN RAPID TEST

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ANDON MEDICAL CO.,LTD IHEALTH COVID-19 ANTIGEN RAPID TEST Back to Search Results
Model Number ICO-3000
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem Insufficient Information (4580)
Event Date 06/11/2022
Event Type  malfunction  
Event Description
Complaint information: ordered two cases of 180 ihealth covid-19 antigen tests from sunline supply for use by our theatreemployees. Our covid compliance officer reported that 45% of the tests from sunline supply cameout blank, with no control line, and many had reagent tubes that were empty.
 
Manufacturer Narrative
1. The customer does not provide specific batch information, and cannot confirm the true condition of the product or test the reserved sample. 2. Customers buy through sunline(https://sunlinesupply. Com/shop/test-kits/covid-otc-rapid-antigen-test-kitsihealth-box-of-2-tests-carton/), but sunline did not obtain ihealth's authorization to distribute ihealth products in the us. 3. Ihealth labs demand that sunline supply immediately:1. Remove ihealth covid-19 antigen rapid test on your website;2. Provide information regarding your supplier of ihealth covid-19 antigen rapid test, including but not limited to, any transaction documents, shipping documents, communication records, etc. 3. Provide your inventory records (number of test kits related to each lot#).
 
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Brand NameIHEALTH
Type of DeviceCOVID-19 ANTIGEN RAPID TEST
Manufacturer (Section D)
ANDON MEDICAL CO.,LTD
tianjin, airport economic area 30030 8
CH 300308
Manufacturer (Section G)
ANDON MEDICAL CO.,LTD
tianjin, airport economic area 30030 8
CH 300308
Manufacturer Contact
ren jun
tianjin, airport economic area 30030-8
CH   300308
MDR Report Key14875152
MDR Text Key303296266
Report Number3008573045-2022-00136
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00208563205894
UDI-Public208563205894
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EUA210470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 06/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberICO-3000
Was Device Available for Evaluation? No
Date Manufacturer Received06/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberMW5110301

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