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

Lot Number REF L031-118B5

Device Problems Product Quality Problem (1506); Device Markings/Labelling Problem (2911); Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 08/09/2022

Event Type  malfunction  

Event Description

I received counterfeit flowflex covid_19 antigen home tests from the website ( rapid health pro) at their mailing address is (b)(6).I compared these test kits to the pictures and info.Given for the same tests on medicares website.Their were several differences.Tests i received had no lot number, expiration date, instruction booklet was missing a language, outside corners of box were missing labels, markings on packages inside of box are different.Fda safety report id# (b)(4).

• Brand Name: FLOWFLEX COVID-19 ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 15241023
• MDR Text Key: 298198991
• Report Number: MW5111496
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: REF L031-118B5
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White