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

Lot Number COV1100046

Device Problems Labelling, Instructions for Use or Training Problem (1318); Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  malfunction  

Event Description

Used a new acon flowflex covid-19 rapid test with all the correct packaging for the fda approved test but noticed that the actual test unit says "sars-cov-2-ag" which is the test that hasn't been approved by the fda (https://www.Fda.Gov/medicaldevices/ safety-communications/do-not-use-certain-acon-flowflex-covid-19 -tests-fda-safety-communication).This lack of quality assurance is worrying knowing that there could be an entire batch of tests with the proper fda approved packaging but in reality is the incorrect, unapproved test when opened.Included photos of the packaging, test, and lot numbers.Covid testing at home.

• Brand Name: ACON FLOWFLEX COVID-19 ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 14843508
• MDR Text Key: 294941896
• Report Number: MW5110540
• 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: 06/24/2022

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: 10/17/2022
• Device Lot Number: COV1100046
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2022
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Race: Asian