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

Model Number L031-118B5

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 05/07/2023

Event Type  malfunction  

Event 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
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 16910930
• MDR Text Key: 315090254
• Report Number: MW5117450
• 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: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Male