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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
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ABBOTT DIAGNOSTICS SCABOROUGH BINAXNOW COVID-19 HOME TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 Back to Search Results
Catalog Number 195-2000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.
 
Event Description
The customer reported conflicting results with the customer reported a false positive result with the id now covid-19 assay performed on (b)(6) 2021 on a on a direct tested nasal kitted swab.Repeat testing was not performed.Confirmation testing on nasal swabs with pcr genrating negative results.The customer stated the patient was symptomatic.No additional patient information, including treatment and outcome, was provided.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
 
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Brand Name
BINAXNOW COVID-19 HOME TEST
Type of Device
LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCABOROUGH
10 southgate road
scarborough ME 04074
MDR Report Key11795106
MDR Text Key280682403
Report Number1221359-2021-01446
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
PMA/PMN Number
EUA202537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number195-2000
Device Lot Number139575
Date Manufacturer Received04/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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