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

Catalog Number 195-160

Patient Problem Insufficient Information (4580)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

I received the 8 covid-19 test kits from the usps this week, as per the latest announcement in november 2023 that we could send for free test kits.However, all of the ones i received will expire in 2 months, even with the extended expiration dates.These kits are made by abbott (binax now brand) with a lot number of 203814, a printed expiration date of july 21st 2023.The online file for this brand says the extended expiration date is february 21st, 2024, just 2 months from now.I have verified this with the cdc phone line for ordering test kits; it has a way to check for the extended expiration dates based on the lot number.I don't know what to do about this, because they will be worthless in 2 months, and i do not know if any additional programs will be approved.Reference reports: mw5149554, mw5149555, mw5149556, mw5149557, mw5149558, mw5149559, mw5149560.

• 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: 18397414
• MDR Text Key: 331438396
• Report Number: MW5149553
• 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: 12/21/2023

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: 02/21/2024
• Device Catalogue Number: 195-160
• Device Lot Number: 203814
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2023
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White