MAUDE Adverse Event Report: COVID-19 RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number COVSC207NB

Device Problems Product Quality Problem (1506); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2023

Event Type  malfunction  

Event Description

Reporter called stating she has received fraudulent covid tests in the mail.She stated that the return address says cipher labs and when she tried calling the number, she reached a recording that stated they are not sending out covid-19 tests and if you receive one, they are fraudulent and to report it to your local police department.She stated the label says the shelf life has been extended and there is a new sticker placed on the box with updated expiration information.She stated the box says celltrion diatrust, but the sticker says cipher labs.Ref report: mw5117227.

• Brand Name: COVID-19 RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 16868134
• MDR Text Key: 314582401
• Report Number: MW5117228
• 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: 05/03/2023

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 Expiration Date: 12/18/2023
• Device Lot Number: COVSC207NB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2023
• Patient Sequence Number: 1
• Patient Sex: Female