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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19 AG CARD HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT BINAXNOW COVID-19 AG CARD HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Model Number BINAXNOW COVID-19 AG CARD HOME T
Device Problems Product Quality Problem (1506); Component Missing (2306); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 12/06/2021
Event Type  malfunction  
Event Description
Abbott "binaxnow covid-19 ag card home test", lot 1413200, delivered with empty reagent bottle: "covid-19ag card extraction reagent", lot#: g0126470 / exp. 10/01/2021. Test kit failed to perform desired test due to empty reagent bottle. Emed was proctoring the test and witnessed the failure. Matter reported to abbott: case (b)(6) matter reported to emed: ticket number: (b)(6), requested replacement kit, but none has been delivered nor scheduled. Kit failed to perform test. Fda safety report id# (b)(4).
 
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Brand NameBINAXNOW COVID-19 AG CARD HOME TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT
MDR Report Key13141613
MDR Text Key283154164
Report NumberMW5106394
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00811877011330
UDI-Public(01)00811877011330
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/29/2021
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 Date09/28/2021
Device Model NumberBINAXNOW COVID-19 AG CARD HOME T
Device Catalogue NumberBINAXNOW COVID-19 AG CARD HOME
Device Lot Number141320
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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