MAUDE Adverse Event Report: ABBOTT BINAX NOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number UPC 11877-01140

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

The binax now test kit label on the outside of the box has a lot number and expiration date that is different than the lot number and expiration date on the products inside the box.Photos are from two different sealed kits.Fda safety report id # (b)(4).

Event Description

The binax now test kit label on the outside of the box has a lot number and expiration date that is different than the lot number and expiration date on the products inside the box.Photos are from two different sealed kits.Fda safety report id # (b)(4).

• Brand Name: BINAX NOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13591738
• MDR Text Key: 286151161
• Report Number: MW5107643
• 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: 02/18/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UPC 11877-01140
• Device Lot Number: 175852
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White