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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. RAPID RESULT COVID-19 TEST E-013306-BNX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. RAPID RESULT COVID-19 TEST E-013306-BNX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Test Result (2695)
Event Type  malfunction  
Event Description
We tested our family of 4 at a public rapid testing site (local fire station) available on (b)(6) 2020 in (b)(6). This first test was taken at 3:06pm. Within 20 minutes we got the result that our son received a positive result 2 days later on (b)(6) at 11:15 we tested him pcr form through our local hospital (b)(6) and got the results back as being not detected. Being parents, we wanted to know exactly what was happening with our son. Due to this we got the whole family tested again a week later on (b)(6) 2021 at 9:04 and all had negative results. Because of what's listed above, i feel that we were given a false positive result for the first test. Fda safety report id # (b)(4).
 
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Brand NameRAPID RESULT COVID-19 TEST E-013306-BNX
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
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MDR Report Key11177316
MDR Text Key227495512
Report NumberMW5098830
Device Sequence Number1
Product Code QKP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 01/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

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