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TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
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2016
2017
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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
20
20
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
Leak/Splash
61
61
Break
44
44
Air/Gas in Device
19
19
Appropriate Term/Code Not Available
17
17
Fire
12
12
Circuit Failure
9
9
Defective Device
9
9
Output Problem
9
9
Adverse Event Without Identified Device or Use Problem
8
8
Smoking
8
8
Gas/Air Leak
8
8
Thermal Decomposition of Device
7
7
False Negative Result
7
7
Sparking
6
6
Use of Device Problem
6
6
Off-Label Use
5
5
Electrical Shorting
5
5
Device Emits Odor
4
4
Loose or Intermittent Connection
4
4
Detachment of Device or Device Component
4
4
Material Discolored
4
4
Device Ingredient or Reagent Problem
3
3
Device Sensing Problem
3
3
Electrical /Electronic Property Problem
3
3
Crack
3
3
Insufficient Information
3
3
Temperature Problem
3
3
Unexpected Color
3
3
Complete Blockage
2
2
Device Alarm System
2
2
Obstruction of Flow
2
2
Melted
2
2
Improper or Incorrect Procedure or Method
2
2
Communication or Transmission Problem
2
2
Intermittent Program or Algorithm Execution
2
2
Fracture
2
2
Unintended Electrical Shock
1
1
Infusion or Flow Problem
1
1
Material Twisted/Bent
1
1
False Positive Result
1
1
Program or Algorithm Execution Failure
1
1
Power Problem
1
1
Defective Component
1
1
Product Quality Problem
1
1
Suction Failure
1
1
Corroded
1
1
Material Integrity Problem
1
1
Misconnection
1
1
Failure to Deliver
1
1
Material Puncture/Hole
1
1
Component Missing
1
1
Failure to Pump
1
1
Degraded
1
1
No Apparent Adverse Event
1
1
Intermittent Energy Output
1
1
Suction Problem
1
1
Intermittent Continuity
1
1
Insufficient Heating
1
1
Device Displays Incorrect Message
1
1
Contamination /Decontamination Problem
1
1
Mechanics Altered
1
1
Unable to Obtain Readings
1
1
Overheating of Device
1
1
Inaccurate Delivery
1
1
Failure to Align
1
1
Display or Visual Feedback Problem
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Protective Measures Problem
1
1
Loss of Power
1
1
Patient Data Problem
1
1
Alarm Not Visible
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
699
699
No Known Impact Or Consequence To Patient
325
325
No Consequences Or Impact To Patient
26
26
Insufficient Information
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
Biocare Medical, LLC
II
Apr-01-2021
2
Dako Denmark A/S
II
May-21-2020
3
Hardy Diagnostics
II
Jun-09-2021
4
Roche Diagnostics Operations, Inc.
II
Oct-08-2020
5
Ventana Medical Systems Inc
II
Jul-12-2022
6
Ventana Medical Systems Inc
II
Apr-08-2022
7
Ventana Medical Systems Inc
II
Jun-05-2020
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