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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 OTC 2 TEST PACK LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195-160
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2021
Event Type  malfunction  
Manufacturer Narrative
This investigation is still in progress. Once the investigation is completed, a supplemental report will be provided.
 
Event Description
The consumer reported a false positive result using the binaxnow¿ covid-19 antigen self test otc, 2 test pack on (b)(6) 2021. The consumer reported that she generated a negative result using an unspecified rapid covid-19 test. Technical services (ts) advised that the consumer obtain a pcr confirmation test. The consumer confirmed that she had taken a pcr test and is awaiting the results. Ts was unsuccessful in obtaining a response to follow ups regarding the results of the pcr test taken by the consumer. The consumer did not indicate to ts if symptoms were present. As of this report, no further information is available. No additional patient information, including treatment and outcome, was provided.
 
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Brand NameBINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK
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, ME 04074
6613888803
MDR Report Key13119330
MDR Text Key284186101
Report Number1221359-2021-03912
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011408
UDI-Public01008118770114081722032010160048
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
Type of Report Initial,Followup
Report Date 06/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/20/2022
Device Catalogue Number195-160
Device Lot Number160048
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received05/31/2022
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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