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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD VERITOR PLUS ANALYZER SARS COV2 LATERAL FLOW ASSAY ANTIGEN POINT OF CARE CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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BD BD VERITOR PLUS ANALYZER SARS COV2 LATERAL FLOW ASSAY ANTIGEN POINT OF CARE CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Lot Number 0213905
Device Problem False Positive Result (1227)
Patient Problem Test Result (2695)
Event Date 10/02/2020
Event Type  malfunction  
Event Description
Apparent false positive result for covid. Using the bd veritor plus analyzer sars cov2 antigen assay, a positive result was obtained in an asymptomatic exposed healthcare worker at an rcfe. A pcr assay from a simultaneously obtained np swab was negative by assay at our regional public health lab. (b)(6). Fda safety report id# (b)(4).
 
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Brand NameBD VERITOR PLUS ANALYZER SARS COV2 LATERAL FLOW ASSAY ANTIGEN POINT OF CARE
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
BD
MDR Report Key10704073
MDR Text Key212304283
Report NumberMW5097322
Device Sequence Number1
Product Code QKP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0213905
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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