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

Catalog Number 195-160

Device Problems Component Missing (2306); Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

Bought a binaxnow covid-19 test at walgreens in (b)(6).The tamper proof seals were in tact.The test was missing english instructions and only included instructions in spanish (ifu tb000054 rev.4 was included).The liquid/reagent required to do the test was also not included in the box.The box only contained the spanish ifu, 2 swabs, and 2 test cards.Fda safety report id# (b)(4).

• 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: 15561979
• MDR Text Key: 301654477
• Report Number: MW5112465
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 00811877011408
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 211966
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female