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U.S. Department of Health and Human Services

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

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Model Number 195-160
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Insufficient Information (4580)
Event Date 01/22/2022
Event Type  malfunction  
Event Description
Purchased qty 2 of abbott binaxnow kits (with two tests/kit).Package label/sticker says manufactured 1-4-2022 and expired 12-08-2020.Impossible.Concerned these are counterfeit and not confident in the tests.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 DIAGNOSTICS SCARBOROUGH, INC.
MDR Report Key13393522
MDR Text Key284867468
Report NumberMW5107061
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 01/27/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date12/08/2022
Device Model Number195-160
Device Lot Number177745
Patient Sequence Number1
Patient Age46 YR
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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