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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
Catalog Number 195-160
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2022
Event Type  malfunction  
Event Description
The costumer reported four(4) false negative patient result with the binax now covid-19 antigen self-test performed on multiple dates throughout the first week of (b)(6) 2022. This mfr. Report addresses patient result three (3) of four (4). The consumer reported a false negative result with the binax now covid-19 antigen self-test performed on (b)(6) 2022 using a kitted nasal swab sample that generated a negative result. Confirmation pcr testing was performed on (b)(6) 2022 at a local pharmacy that generated a positive result. No additional patient information, including treatment and outcome, was provided.
 
Manufacturer Narrative
This report is being submitted to provide the initial report and investigation conclusion. Testing was performed at abbott diagnostics scarborough, inc. On retained kit lot 187871 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 187871 and device part number 195-430h / lot 184143. The lot met the required release specifications. (b)(4). In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample. Please reference mfr report numbers: 1221359-2022-04315, and 1221359-2022-04336 - 1221359-2022-04338.
 
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Brand NameBINAXNOW COVID-19 ANTIGEN SELF TEST
Type of DeviceCORONAVIRUS 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
MDR Report Key15325591
MDR Text Key302946016
Report Number1221359-2022-04337
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public01008118770114081723051210187871
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
Report Date 08/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number195-160
Device Lot Number187871
Was Device Available for Evaluation? No
Date Manufacturer Received08/10/2022
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

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