Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE INTL. PTE LTD. AUTOSTAINER LINK 48; AUTOMATED SLIDE STAINER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AGILENT TECHNOLOGIES SINGAPORE INTL. PTE LTD. AUTOSTAINER LINK 48; AUTOMATED SLIDE STAINER Back to Search Results
Model Number AS480
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Event Description
Customer reported reagent tip was dripping after washing the buffer.Issue was attributed to a dispense check valve and probe malfunction.Field service engineer replaced the parts.Instrument is fully operational and ready for use.No indication of a delay in diagnosis.
 
Manufacturer Narrative
The dispense check valve and probe malfunction may potentially impact staining.No delay to testing was reported.No patient or user harm was indicated.Patient information has not been provided by the user.
 
Manufacturer Narrative
The dispense check valve and probe malfunction may potentially impact staining.No delay to testing was reported.No patient or user harm was indicated.Patient information has not been provided by the user.
 
Event Description
Customer reported reagent tip was dripping after washing the buffer.Issue was attributed to a dispense check valve and probe malfunction.Field service engineer replaced the parts.Instrument is fully operational and ready for use.No indication of a delay in diagnosis.
 
Event Description
Customer reported reagent tip was dripping after washing the buffer.Issue was attributed to a dispense check valve and probe malfunction.Field service engineer replaced the parts.Instrument is fully operational and ready for use.No indication of a delay in diagnosis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AUTOSTAINER LINK 48
Type of Device
AUTOMATED SLIDE STAINER
Manufacturer (Section D)
AGILENT TECHNOLOGIES SINGAPORE INTL. PTE LTD.
no.1 yishun avenue 7
singapore north east, 76892 3
SG  768923
Manufacturer (Section G)
SHANDON DIAGNOSTICS LIMITED
tudor road, manor park
runcom, cheshire WA7 1 TA
UK   WA7 1TA
Manufacturer Contact
bryce portier
1834 state highway 71 west
cedar creek, TX 78612
4082185467
MDR Report Key13118815
MDR Text Key285182871
Report Number3003423869-2021-00313
Device Sequence Number1
Product Code KPA
UDI-Device Identifier05700572035497
UDI-Public05700572035497
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model NumberAS480
Device Catalogue NumberAS48030
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-