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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, automated blood grouping and antibody
Product CodeKSZ
Regulation Number 864.9175
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 2
BIO-RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 17
DIAGNOSTIC GRIFOLS, S. A.
  SUBSTANTIALLY EQUIVALENT 18
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 19
MICRO TYPING SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 5
OLYMPUS AMERICA INC., DIAGNOSTIC SYSTEMS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRATEC BIOMEDICAL UK LIMITED
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 526 526
2015 485 485
2016 620 620
2017 626 626
2018 686 686
2019 298 301
2020 75 142
2021 76 213
2022 78 156
2023 151 179
2024 13 23

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 2236 2520
Incorrect, Inadequate or Imprecise Result or Readings 416 454
False Positive Result 415 450
Incorrect Or Inadequate Test Results 222 222
Device Operates Differently Than Expected 107 107
Adverse Event Without Identified Device or Use Problem 85 85
Defective Component 50 50
Defective Device 45 45
Display Difficult to Read 40 40
Improper or Incorrect Procedure or Method 36 36
Output Problem 19 19
Computer Software Problem 13 13
Incorrect Measurement 12 12
Device Displays Incorrect Message 11 11
Insufficient Information 10 10
Data Problem 9 9
Device Expiration Issue 9 9
Unexpected Therapeutic Results 7 7
Patient-Device Incompatibility 7 7
Improper Device Output 7 7
False Reading From Device Non-Compliance 7 7
Inadequate Instructions for Healthcare Professional 7 7
Device Alarm System 7 7
Patient Data Problem 7 7
Inaccurate Information 7 7
Break 6 6
Use of Device Problem 6 6
Component Missing 6 6
Device Ingredient or Reagent Problem 5 5
Leak/Splash 5 5
Non Reproducible Results 5 13
Device Maintenance Issue 4 4
Fluid/Blood Leak 4 4
Poor Quality Image 4 4
Alarm Not Visible 4 4
Component Falling 4 4
Improper Chemical Reaction 4 4
Device Markings/Labelling Problem 3 3
Application Program Problem 3 3
Smoking 3 3
Contamination 3 3
Use of Incorrect Control/Treatment Settings 3 3
Mechanical Problem 3 5
Display or Visual Feedback Problem 3 3
Electrical /Electronic Property Problem 3 3
Missing Test Results 3 3
Naturally Worn 3 3
Misassembly by Users 3 3
Output below Specifications 2 2
Application Program Problem: Medication Error 2 2
Failure to Power Up 2 2
Nonstandard Device 2 2
Occlusion Within Device 2 2
No Display/Image 2 2
Bent 2 2
Device Reprocessing Problem 2 2
Failure to Read Input Signal 2 2
Self-Activation or Keying 2 2
High Test Results 2 2
Sparking 2 2
Expiration Date Error 2 2
Connection Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Compatibility Problem 2 2
Incorrect Device Or Component Shipped 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Twisted/Bent 1 1
Optical Problem 1 1
Computer Operating System Problem 1 1
Fail-Safe Problem 1 1
Failure of Device to Self-Test 1 1
Failure to Obtain Sample 1 1
Low Readings 1 1
Failure to Deliver 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Inadequate or Insufficient Training 1 1
Complete Blockage 1 1
Coagulation in Device or Device Ingredient 1 1
Burst Container or Vessel 1 1
Calibration Error 1 1
Circuit Failure 1 1
Air Leak 1 1
Crack 1 1
Cross Reactivity 1 1
Positioning Failure 1 1
Disassembly 1 1
Device Emits Odor 1 1
Output above Specifications 1 1
Overheating of Device 1 1
Power Conditioning Problem 1 1
Product Quality Problem 1 1
Misassembled 1 1
Image Display Error/Artifact 1 1
Imprecision 1 1
Excess Flow or Over-Infusion 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Unintended Electrical Shock 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2237 2253
No Consequences Or Impact To Patient 774 774
No Clinical Signs, Symptoms or Conditions 299 435
No Information 82 82
Reaction 53 53
Test Result 45 52
No Code Available 40 40
Insufficient Information 30 194
Patient Problem/Medical Problem 13 13
Injury 12 12
No Patient Involvement 11 11
Fever 8 8
Hemolysis 7 7
Laceration(s) 6 6
Death 5 5
Headache 5 5
Low Blood Pressure/ Hypotension 4 4
Pain 4 4
Complaint, Ill-Defined 4 4
Jaundice 4 4
Chills 3 3
Electric Shock 3 3
Exposure to Body Fluids 3 3
Hemorrhage/Bleeding 2 2
Chemical Exposure 2 2
Therapeutic Effects, Unexpected 2 2
Venipuncture 2 2
Nausea 1 1
Overdose 1 1
Urticaria 1 1
Anxiety 1 1
Blood Loss 1 1
Hematuria 1 1
Missed Dose 1 1
Needle Stick/Puncture 1 1
Hyperbilirubinemia 1 1
Hypoxia 1 1
Pneumonia 1 1
Rash 1 1
Respiratory Distress 1 1
Tachycardia 1 1
Bruise/Contusion 1 1
Airway Obstruction 1 1
Autoimmune Reaction 1 1
Hearing Loss 1 1
Bone Fracture(s) 1 1
Alteration In Body Temperature 1 1
Pregnancy 1 1
Unspecified Tissue Injury 1 1
Reaction to Medicinal Component of Device 1 1

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