MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19 TEST KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 193606

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

I was going to perform a covid antigen test using a binaxnow covid-19 test kit.The kit was supposed to include sufficient supplies for 2 tests.However, there were no reagent bottles at all.This was a kit received via the usps lot193606 (ref 195-160).The package was sealed so there is no possibility that the tubes of reagent were lost in transit.I went to the abbott facebook page and found that other individuals were complaining about the same issue https://www.Facebook.Com/abbott/posts/have-questions-about-our-binaxnow-covid-19-self-test-heres-a-step-by-step-video-/4003620956360706/.

• Brand Name: BINAXNOW COVID-19 TEST KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 16397970
• MDR Text Key: 309889445
• Report Number: MW5115000
• 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: 02/14/2023

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: 05/17/2023
• Device Lot Number: 193606
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White