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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 LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195-160
Device Problems False Negative Result (1225); False Positive Result (1227)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Event Description
The customer reported four (4) false negative results with the id now covid-19 assay performed between (b)(6) 2022 and (b)(6) 2022, with one test being taken on (b)(6) 2022 after the pcr test was performed. This report is tests four (4) of four (4). Pcr testing was performed on (b)(6) 2022 and generated a positive result. No additional information regarding outcome was provided.
 
Manufacturer Narrative
The remainder of the investigation remains in progress. A supplemental report will be provided after completion. Please refer to related mfr report numbers: 1221359-2022-03188 through 1221359-2022-03190.
 
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Brand NameBINAXNOW COVID-19 ANTIGEN SELF-TEST
Type of DeviceLATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
10 southgate road
scarborough,
ME 04074
Manufacturer Contact
rachel blackwell
10 southgate road
scarborough,
MDR Report Key14830424
MDR Text Key295062317
Report Number1221359-2022-03185
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public01008118770114081723031610186666
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 10/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number195-160
Device Lot Number186666
Was Device Available for Evaluation? No
Date Manufacturer Received10/06/2022
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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