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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
Regulation Description Automated slide stainer.
Product CodeKPA
Regulation Number 864.3800
Device Class 1

MDR Year MDR Reports MDR Events
2020 436 436
2021 323 323
2022 161 161
2023 125 125
2024 99 99
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 455 455
Mechanical Problem 324 324
Fluid/Blood Leak 239 239
Break 123 123
Structural Problem 111 111
Activation, Positioning or Separation Problem 87 87
Therapeutic or Diagnostic Output Failure 86 86
Leak/Splash 59 59
Air/Gas in Device 19 19
Appropriate Term/Code Not Available 17 17
Fire 11 11
Output Problem 10 10
Circuit Failure 9 9
False Negative Result 9 9
Defective Device 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Gas/Air Leak 8 8
Sparking 7 7
Use of Device Problem 7 7
Smoking 6 6
Off-Label Use 5 5
Device Fell 5 5
Improper or Incorrect Procedure or Method 4 4
Loose or Intermittent Connection 4 4
Detachment of Device or Device Component 4 4
Thermal Decomposition of Device 4 4
Material Discolored 4 4
Temperature Problem 3 3
Electrical /Electronic Property Problem 3 3
Overheating of Device 3 3
Excessive Heating 3 3
Device Sensing Problem 3 3
Device Emits Odor 3 3
Unexpected Color 3 3
Device Ingredient or Reagent Problem 3 3
Crack 3 3
Insufficient Information 3 3
Contamination /Decontamination Problem 2 2
Obstruction of Flow 2 2
Material Twisted/Bent 2 2
Unintended Power Up 2 2
Intermittent Program or Algorithm Execution 2 2
Complete Blockage 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Device Remains Activated 1 1
Low Test Results 1 1
Device Displays Incorrect Message 1 1
False Positive Result 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 788 788
No Known Impact Or Consequence To Patient 312 312
Insufficient Information 28 28
No Consequences Or Impact To Patient 22 22
Blister 2 2
Fall 2 2
Laceration(s) 2 2
Unspecified Tissue Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Bruise/Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Distress 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Burn(s) 1 1
Discomfort 1 1
Pain 1 1
Limb Fracture 1 1
Swelling/ Edema 1 1
Headache 1 1
Hemorrhage/Bleeding 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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