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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 6
DIAGNOSTIC GRIFOLS, S. A.
  SUBSTANTIALLY EQUIVALENT 11
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 10
MICRO TYPING SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
STRATEC BIOMEDICAL UK LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 298 301
2020 75 142
2021 76 213
2022 78 156
2023 151 179
2024 41 69

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 310 612
Incorrect, Inadequate or Imprecise Result or Readings 192 230
False Positive Result 111 158
Adverse Event Without Identified Device or Use Problem 54 54
Improper or Incorrect Procedure or Method 15 15
Defective Device 15 15
Defective Component 11 11
Computer Software Problem 8 8
Leak/Splash 5 5
Non Reproducible Results 5 13
Alarm Not Visible 4 4
Device Displays Incorrect Message 3 3
Naturally Worn 3 3
Data Problem 3 3
Insufficient Information 3 3
Patient-Device Incompatibility 3 3
Low Readings 2 2
Component Missing 2 2
Failure to Power Up 2 2
Contamination 2 2
Mechanical Problem 2 4
Output Problem 2 2
Failure to Read Input Signal 2 2
Smoking 1 1
Failure to Clean Adequately 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Obtain Sample 1 1
Erratic Results 1 1
Image Display Error/Artifact 1 1
Failure to Deliver 1 1
Use of Device Problem 1 1
Unintended Electrical Shock 1 1
No Display/Image 1 1
Material Twisted/Bent 1 1
Positioning Failure 1 1
Break 1 1
Excess Flow or Over-Infusion 1 1
Missing Test Results 1 1
Misassembly During Maintenance/Repair 1 1
Physical Resistance/Sticking 1 1
Device Handling Problem 1 1
Device Emits Odor 1 1
Incorrect Measurement 1 1
No Apparent Adverse Event 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Nonstandard Device 1 1
Inadequate or Insufficient Training 1 1
Coagulation in Device or Device Ingredient 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 323 477
No Known Impact Or Consequence To Patient 266 282
No Consequences Or Impact To Patient 48 48
Insufficient Information 30 194
Reaction 13 13
Test Result 11 18
Patient Problem/Medical Problem 8 8
Fever 4 4
No Information 3 3
Injury 3 3
No Patient Involvement 3 3
Hemolysis 2 2
No Code Available 2 2
Exposure to Body Fluids 2 2
Hemorrhage/Bleeding 2 2
Non specific EKG/ECG Changes 1 1
High Blood Pressure/ Hypertension 1 1
Electric Shock 1 1
Hearing Loss 1 1
Hyperbilirubinemia 1 1
Nausea 1 1
Respiratory Distress 1 1
Hematuria 1 1
Bone Fracture(s) 1 1
Reaction to Medicinal Component of Device 1 1
Rash 1 1
Chills 1 1
Chest Pain 1 1
Laceration(s) 1 1
Pneumonia 1 1
Tachycardia 1 1
Anxiety 1 1
Shaking/Tremors 1 1
Unspecified Tissue Injury 1 1
Hypoxia 1 1
Headache 1 1
Airway Obstruction 1 1

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