MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID 19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number	L031-118B5
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Flowflex covid 19 antigen being sold at cvs in (b)(6) near (b)(6) has two expiry dates printed.The one outside says expiry at the end of 2023 but the pouch inside says it expired in march of 2023.This is deceptive labelling by the manufacturer and will give false negative results as a result.

• Brand Name: FLOWFLEX COVID 19 ANTIGEN TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 16910930
• Report Number: MW5117450
• Device Sequence Number: 6017328
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: (01)00682607660261
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/07/2023

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: 10/01/2023
• Device Model Number: L031-118B5
• Device Catalogue Number: 660261
• Device Lot Number: COV2030019
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2023
• Patient Sequence Number: 1
• Patient Sex: Male