MAUDE Adverse Event Report: ABBOTT ABBOTT BINAX NOW COVID 19 HOME TESTS; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

I purchased the abbott binax now covid home test on (b)(6) on the (b)(6) website.I bought four of them and used two while on a trip to (b)(6) in (b)(6) 2021.These tests were highly recommended on (b)(6) website on its international travel page.On saturday, (b)(6) 2022, i was thinking about taking another covid test since i felt like i was getting a cold.Since i still had two from my order, i was going to just use this test.As i was looking at the package i noticed that the tests expired on september 18, 2021 i ordered on (b)(6).I phoned the (b)(6) on monday, (b)(6) 2022, to tell them about the expired tests they had sent me.The customer service rep i spoke to said that there was a disclaimer on their website saying to disregard the expiration date because they would be good for another three months and that recently the fda had approved them for another three months.I told her i did not see a disclaimer, but it was a moot point so i hung up.I then went to their website and looked at the product information for this test, and low and behold, no disclaimer.In fact, the information says that the fda has not approved this test.See link: (b)(6) "the binaxnow? covid-19 ag card home test has not been fda cleared or approved." the rep lied to me about the disclaimer none is listed, and the fda hasn't even approved these tests.This is very disturbing given that people are using these expired tests.I took this test while in (b)(6) to return to the us late (b)(6) 2021.Thank you for looking into this situation.(b)(6) needs to be punished for their negligence.

• Brand Name: ABBOTT BINAX NOW COVID 19 HOME TESTS
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13479652
• MDR Text Key: 285458770
• Report Number: MW5107264
• Device Sequence Number: 2
• 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: 02/04/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/18/2021
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White