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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGILENT TECHNOLOGIES, INC. FLEX MONOCLONAL MO A HU CYTOKER, CLONE AE1/AE3, RTU, LINK JAPAN

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AGILENT TECHNOLOGIES, INC. FLEX MONOCLONAL MO A HU CYTOKER, CLONE AE1/AE3, RTU, LINK JAPAN Back to Search Results
Model Number IR053
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2021
Event Type  malfunction  
Manufacturer Narrative
Root cause: unknown, investigation is ongoing. Failure mode description: unknown, investigation is ongoing. Therefore, this report is being filed as part of agilent's commitment to due diligence reporting. Supplemental will be submitted once additional information is received.
 
Event Description
Customer complaint record reported the event as follows: non-specific staining of the flex monoclonal mouse antibody clone ae1/ae3 used with the autostainer link 48. No direct or indirect patient harm or user harm have been reported.
 
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Brand NameFLEX MONOCLONAL MO A HU CYTOKER, CLONE AE1/AE3, RTU, LINK JAPAN
Type of DeviceFLEX MONOCLONAL MO A HU CYTOKER, CLONE AE1/AE3, RTU, LINK JAPAN
Manufacturer (Section D)
AGILENT TECHNOLOGIES, INC.
5301 stevens creek blvd.
santa clara CA 95051
Manufacturer (Section G)
AGILENT TECHNOLOGIES, INC.
5301 stevens creek blvd.
santa clara CA 95051
Manufacturer Contact
sonia siddique
1834 tx-71 w
cedar creek, TX 78612
5123328112
MDR Report Key11270828
MDR Text Key231005752
Report Number2916205-2021-00002
Device Sequence Number1
Product Code NJT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIR053
Device Catalogue NumberIR05361-2J
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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