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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 159341
Device Problems Use of Device Problem (1670); Component Missing (2306); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 12/23/2021
Event Type  malfunction  
Event Description
I opened an abbott binaxnow covid-19 at-home test kit on (b)(6) 2021.I had purchased this test kit from (b)(6) on (b)(6) 2021 and but hadn't needed to use it until (b)(6).The test kit box was sealed, and upon opening it i discovered that the two reagent bottles were missing from the box.As you know, the test kits are rendered unusable without the reagent solution, so i was not able to use either of the two tests in the box.I contacted abbott (the manufacturer) on (b)(6), and while the person took down the lot numbers and other pertinent box information, they said it was (b)(6) responsibility to issue a replacement or refund.(abbott case # (b)(4)) i would think that since it was obviously a manufacturer error, it would be the responsibility of the manufacturer to replace it.I contacted (b)(6) customer service on (b)(6) and they issued a refund.The issue has been resolved, but i would think the manufacturer should have to bear more of the responsibility for the defective test kit.Fda safety report id# (b)(4).
 
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Brand Name
BINAXNOW COVID-19 ANTIGEN SELF TEST
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT
MDR Report Key13117928
MDR Text Key283141504
Report NumberMW5106354
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date04/01/2022
Device Lot Number159341
Was Device Available for Evaluation? Yes
Patient Sequence Number1
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