MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX SARS-COV-2 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number BLUE BOX

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

Ordered 5 flowflex covid tests from (b)(6) and received the tests in the blue box which are not fda authorized and have been recalled.In their presentation they showed the ones in the white box which are fda approved.Fda safety report id# (b)(4).

• Brand Name: FLOWFLEX SARS-COV-2 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 13314629
• MDR Text Key: 284313059
• Report Number: MW5106839
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/18/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/08/2023
• Device Model Number: BLUE BOX
• Device Lot Number: COV1105016
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2022
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White