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

Device Problems Defective Device (2588); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2021

Event Type  malfunction  

Event Description

I purchased 4 abbot binax now covid test kits since they were authorized for travel.One for each of myself, my wife, my brother in law and my sister in law.All of the test kits expired before the date of purchase, the reagents for all of them expired 2 days after i received them, and even worse when we opened two of the kits in (b)(6) the reagent bottles were completely empty.Fda safety report id # (b)(4).

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12786865
• MDR Text Key: 280712315
• Report Number: MW5105222
• Device Sequence Number: 4
• 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: 11/06/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian