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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device slide stainer, automated
Product CodeKPA
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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