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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 03/22/2024
Event Type  malfunction  
Event Description
The consumer reported two (2) false negative results with the binaxnow covid-19 antigen self test for two tests performed one test on (b)(6) 2024 and another test on an unknown date.This mfr.Report addresses test one (1) of two (2).Additional testing was performed last week at a local health center with an unknown brand test (platform - unknown) which generated a positive result.The consumer stated the patient was currently symptomatic (cough and headache) and was not feeling well.Although requested, no additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
 
Manufacturer Narrative
Correction: a3a - sex the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
 
Event Description
The consumer reported two (2) false negative results with the binaxnow covid-19 antigen self test for two tests performed one test on (b)(6)2024 and another test on an unknown date.This mfr.Report addresses test one (1) of two (2).Additional testing was performed last week at a local health center with an unknown brand test (platform - unknown) which generated a positive result.The consumer stated the patient was currently symptomatic (cough and headache) and was not feeling well.Although requested, no additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 228731b 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 228731b, test base part number 195-430wjr/ lot 224885.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 228731b showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue, however it could have possibly been related to the specific patient sample.
 
Event Description
The consumer reported two (2) false negative results with the binaxnow covid-19 antigen self test for two tests performed one test on (b)(6) 2024 and another test on an unknown date.This mfr.Report addresses test one (1) of two (2).Additional testing was performed last week at a local health center with an unknown brand test (platform - unknown) which generated a positive result.The consumer stated the patient was currently symptomatic (cough and headache) and was not feeling well.Although requested, no additional patient information, including treatment and outcome, was provided.
 
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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 Key19069892
MDR Text Key339787451
Report Number1221359-2024-00332
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public01008118770114081724091810228731B
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,Followup
Report Date 04/23/2024
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 Number228731B
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/22/2024
Initial Date FDA Received04/09/2024
Supplement Dates Manufacturer Received03/22/2024
04/17/2024
Supplement Dates FDA Received04/11/2024
04/23/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/18/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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