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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ABBOTT BINAXNOW AG CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ABBOTT BINAXNOW AG CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Test Result (2695)
Event Date 11/06/2020
Event Type  malfunction  
Event Description
My daughter was given an abbott binaxnow ag card test by her school. Test was not clear, she took test twice. Second line was very faint, school ruled as positive since was test seemed inconclusive. I tested her soon after, twice and both test from independent labs came back negative. I feel that this product does not give the correct results and is handing out false positives. Should be looked into. Fda safety report id# (b)(4).
 
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Brand NameABBOTT BINAXNOW AG
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
MDR Report Key10966936
MDR Text Key220428194
Report NumberMW5098232
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 12/03/2020
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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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