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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
2014 16 16
2015 11 11
2016 31 31
2017 8 8
2018 13 13
2019 26 26
2020 436 436
2021 323 323
2022 161 161
2023 125 125
2024 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 469 469
Mechanical Problem 322 322
Fluid/Blood Leak 256 256
Activation, Positioning or Separation Problem 87 87
Therapeutic or Diagnostic Output Failure 87 87
Break 82 82
Structural Problem 70 70
Leak/Splash 63 63
Appropriate Term/Code Not Available 20 20
Adverse Event Without Identified Device or Use Problem 20 20
Air/Gas in Device 19 19
Fire 15 15
False Negative Result 12 12
Output Problem 10 10
Incorrect Or Inadequate Test Results 10 10
Smoking 10 10
Data Problem 9 9
Insufficient Information 9 9
Sparking 9 9
Circuit Failure 9 9
Defective Device 9 9
Use of Device Problem 8 8
Gas/Air Leak 8 8
Thermal Decomposition of Device 7 7
Device Emits Odor 5 5
Electrical Shorting 5 5
Off-Label Use 5 5
Failure to Align 4 4
Material Discolored 4 4
Calibration Problem 4 4
Detachment of Device or Device Component 4 4
Loose or Intermittent Connection 4 4
False Positive Result 4 4
Improper or Incorrect Procedure or Method 4 4
Device Displays Incorrect Message 4 4
Device Ingredient or Reagent Problem 3 3
Failure to Deliver 3 3
Crack 3 3
Temperature Problem 3 3
Device Sensing Problem 3 3
Inaccurate Delivery 3 3
Unexpected Color 3 3
Electrical /Electronic Property Problem 3 3
Nonstandard Device 3 3
Contamination /Decontamination Problem 2 2
Obstruction of Flow 2 2
Component Missing 2 2
Device Alarm System 2 2
Inaccurate Dispensing 2 2
Intermittent Program or Algorithm Execution 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 740 740
No Known Impact Or Consequence To Patient 364 364
No Consequences Or Impact To Patient 33 33
Insufficient Information 28 28
Fall 13 13
No Code Available 11 11
Injury 11 11
No Information 5 5
Tissue Damage 5 5
Cancer 4 4
Burn(s) 3 3
Pain 3 3
Test Result 2 2
Unspecified Tissue Injury 2 2
Bruise/Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Distress 1 1
Head Injury 1 1
Needle Stick/Puncture 1 1
No Patient Involvement 1 1
Swelling 1 1
Discomfort 1 1
Laceration(s) 1 1
Reaction 1 1
Limb Fracture 1 1
Swelling/ Edema 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular II Aug-31-2010
2 Agilent Technologies II May-29-2024
3 Beckman Coulter Inc II Feb-25-2010
4 Beckman Coulter Inc. II Aug-20-2012
5 BioMerieux SA II Jun-12-2018
6 Biocare Medical, LLC II Apr-01-2021
7 Dako Denmark A/S II May-21-2020
8 Dako Denmark A/S II Dec-19-2012
9 Dako North America Inc. II Apr-29-2015
10 Dako North America Inc. II Mar-16-2015
11 Dako North America Inc. II Sep-26-2014
12 Hardy Diagnostics II Jun-09-2021
13 Hardy Diagnostics II Jul-08-2016
14 Leica Microsystems, Inc. II Oct-26-2018
15 Leica Microsystems, Inc. II Oct-03-2018
16 Roche Diagnostics Operations, Inc. II Oct-08-2020
17 Ventana Medical Systems Inc II Jul-12-2022
18 Ventana Medical Systems Inc II Apr-08-2022
19 Ventana Medical Systems Inc II Jun-05-2020
20 Ventana Medical Systems Inc II Aug-28-2013
21 Ventana Medical Systems Inc II Aug-06-2013
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