MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF-TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number BINAXNOW COVID-19 ANTIGEN SELF-

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

Purchased 2 covid 19 home tests and both sets of tests where defected and multiple people have reported this to the company and they will not do anything about the problem these test aren't cheap.These test should be recalled and refunds should be given.Fda safety report id# (b)(4).

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF-TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 13443336
• MDR Text Key: 285156778
• Report Number: MW5107168
• 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: 01/31/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2022
• Device Model Number: BINAXNOW COVID-19 ANTIGEN SELF-
• Device Catalogue Number: BINAXNOW COVID-19 ANTIGEN SELF
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White