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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Catalog Number 195-160
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Event Description
The consumer reported false negative results with the binaxnow covid-19 antigen self-test kit for four (4) tests performed on two (2) patients on an unknown date.This mfr.Report addresses test two (2) of four (4).The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on an unknown date on an unknown sample type.Additional testing was performed twice on the same day using an indicaid rapid antigen test and a flow flex rapid antigen test which generated positive results each respectively.No additional information, including treatment and outcome, was provided.
 
Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided.D4-udi:(b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.
 
Event Description
The consumer reported false negative results with the binaxnow covid-19 antigen self-test kit for four (4) tests performed on two (2) patients on an unknown date.This mfr.Report addresses test two (2) of four (4).The consumer reported a false negative result with the binaxnow covid-19 antigen self-test performed on an unknown date on an unknown sample type.Additional testing was performed twice on the same day using an indicaid rapid antigen test and a flow flex rapid antigen test which generated positive results each respectively.No additional information, including treatment and outcome, was provided.
 
Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided.D4-udi:(b)(4).Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 225161 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-160/ lot: 225161, test base part number 195-430h/ lot: 221919.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 225161 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could have possibly been related to patient sample.H3 other text : single use; device discarded.
 
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Brand Name
BINAXNOW COVID-19 AG SELF TEST 2CT
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough, ME 04074
6613888803
MDR Report Key18661197
MDR Text Key334787990
Report Number1221359-2024-00155
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/20/2024
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 Operator Lay User/Patient
Device Catalogue Number195-160
Device Lot Number225161
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/24/2024
Initial Date FDA Received02/07/2024
Supplement Dates Manufacturer Received02/16/2024
Supplement Dates FDA Received02/20/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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