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TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
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2016
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2019
2020
2021
2022
2023
2024
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Device
slide stainer, automated
Product Code
KPA
Regulation Number
864.3800
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
26
26
2020
436
436
2021
323
323
2022
161
161
2023
125
125
2024
49
49
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
458
458
Mechanical Problem
321
321
Fluid/Blood Leak
249
249
Activation, Positioning or Separation Problem
87
87
Therapeutic or Diagnostic Output Failure
86
86
Break
72
72
Leak/Splash
61
61
Structural Problem
60
60
Air/Gas in Device
19
19
Appropriate Term/Code Not Available
17
17
Fire
12
12
Output Problem
10
10
Defective Device
9
9
False Negative Result
9
9
Circuit Failure
9
9
Smoking
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Gas/Air Leak
8
8
Sparking
7
7
Thermal Decomposition of Device
7
7
Use of Device Problem
6
6
Electrical Shorting
5
5
Off-Label Use
5
5
Detachment of Device or Device Component
4
4
Loose or Intermittent Connection
4
4
Device Emits Odor
4
4
Material Discolored
4
4
Crack
3
3
Electrical /Electronic Property Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Device Ingredient or Reagent Problem
3
3
Device Sensing Problem
3
3
Temperature Problem
3
3
Insufficient Information
3
3
Unexpected Color
3
3
Intermittent Program or Algorithm Execution
2
2
Obstruction of Flow
2
2
Contamination /Decontamination Problem
2
2
Communication or Transmission Problem
2
2
Melted
2
2
Fracture
2
2
Device Alarm System
2
2
Complete Blockage
2
2
Intermittent Continuity
1
1
Corroded
1
1
Alarm Not Visible
1
1
False Positive Result
1
1
Degraded
1
1
Display or Visual Feedback Problem
1
1
Insufficient Heating
1
1
Misconnection
1
1
Overheating of Device
1
1
Loss of Power
1
1
Suction Problem
1
1
Defective Component
1
1
Component Missing
1
1
Failure to Deliver
1
1
Inaccurate Delivery
1
1
Device Contamination with Chemical or Other Material
1
1
Failure to Pump
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Unable to Obtain Readings
1
1
Device Displays Incorrect Message
1
1
Failure to Align
1
1
Power Problem
1
1
Protective Measures Problem
1
1
Infusion or Flow Problem
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Mechanics Altered
1
1
Naturally Worn
1
1
No Apparent Adverse Event
1
1
Patient Data Problem
1
1
Unintended Electrical Shock
1
1
Intermittent Energy Output
1
1
Program or Algorithm Execution Failure
1
1
Suction Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
727
727
No Known Impact Or Consequence To Patient
325
325
Insufficient Information
27
27
No Consequences Or Impact To Patient
26
26
Fall
10
10
Injury
5
5
Bruise/Contusion
2
2
Pain
2
2
Unspecified Tissue Injury
2
2
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Discomfort
1
1
Limb Fracture
1
1
Respiratory Distress
1
1
Swelling
1
1
Burn(s)
1
1
Head Injury
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Agilent Technologies
II
May-29-2024
2
Biocare Medical, LLC
II
Apr-01-2021
3
Dako Denmark A/S
II
May-21-2020
4
Hardy Diagnostics
II
Jun-09-2021
5
Roche Diagnostics Operations, Inc.
II
Oct-08-2020
6
Ventana Medical Systems Inc
II
Jul-12-2022
7
Ventana Medical Systems Inc
II
Apr-08-2022
8
Ventana Medical Systems Inc
II
Jun-05-2020
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