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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 56 56
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 395 395
Mechanical Problem 328 328
Break 137 137
Structural Problem 130 130
Fluid/Blood Leak 113 113
Leak/Splash 35 35
Air/Gas in Device 19 19
Appropriate Device Problem Term/Code Not Available 16 16
Device Fell 9 9
Circuit Failure 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Sparking 8 8
Fire 8 8
Insufficient Device Problem Information 7 7
Use of Device Problem 7 7
Off-Label Use 7 7
Excessive Heating 7 7
False Negative Result 7 7
Device Remains Activated 5 5
Smoking 5 5
Thermal Decomposition of Device 4 4
Detachment of Device or Device Component 4 4
Device Ingredient or Reagent Problem 3 3
Unexpected Color 3 3
Electrical /Electronic Property Problem 3 3
Temperature Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Program or Algorithm Execution Problem 3 3
No Apparent Adverse Event 2 2
Calibration Problem 2 2
Program or Algorithm Execution Failure 2 2
Overheating of Device 2 2
Unintended Power Up 2 2
Data Problem 2 2
Contamination /Decontamination Problem 2 2
False Positive Result 2 2
Fracture 2 2
Intermittent Program or Algorithm Execution 2 2
Low Test Results 1 1
Obstruction of Flow 1 1
Mechanics Altered 1 1
Power Problem 1 1
Device Emits Odor 1 1
Connection Problem 1 1
Crack 1 1
Unintended Electrical Shock 1 1
Patient Data Problem 1 1
Failure to Pump 1 1
Computer Software Problem 1 1
Misconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 829 829
No Known Impact Or Consequence To Patient 312 312
Insufficient Information 36 36
No Consequences Or Impact To Patient 22 22
Bruise/Contusion 2 2
Unspecified Tissue Injury 2 2
Blister 2 2
Laceration(s) 2 2
Fall 2 2
Partial thickness (Second Degree) Burn 2 2
Burn(s) 1 1
Electric Shock 1 1
Eye Irritation 1 1
Nerve Damage 1 1
Bone Fracture(s) 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Corneal Clouding/Hazing 1 1
Fungal Infection 1 1
Respiratory Distress 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Limb Fracture 1 1
Head Injury 1 1
Swelling/ Edema 1 1
Pain 1 1
Discomfort 1 1
Headache 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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