MAUDE Adverse Event Report: CORDX, INC. CORDX COVID TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 30341

Patient Problem Viral Infection (2248)

Event Type  malfunction  

Event Description

The covid test kits produced by cordx are reported to have serious quality issues.Their products lack of fda certification, and they don't even have a license for the state of (b)(6).I'm unsure how such products are allowed in the u.S.Market and how they manage to secure government orders.I contracted covid last week and tested three times with cordx's product, getting different results each time.This led me to miss the optimal treatment window.Reference reports mw5150474, mw5150475.

• Brand Name: CORDX COVID TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): CORDX, INC.
• MDR Report Key: 18535619
• MDR Text Key: 333251071
• Report Number: MW5150476
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 30341
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Hispanic