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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
Regulation Description Automated blood grouping and antibody test system.
Product CodeKSZ
Regulation Number 864.9175
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 2
BIO-RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC GRIFOLS, S. A.
  SUBSTANTIALLY EQUIVALENT 6
DIAGNOSTIC GRIFOLS, S.A.
  SUBSTANTIALLY EQUIVALENT 3
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 8
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2021 76 218
2022 78 158
2023 151 186
2024 66 130
2025 66 221
2026 4 32

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 136 590
Incorrect, Inadequate or Imprecise Result or Readings 120 158
False Positive Result 83 216
Adverse Event Without Identified Device or Use Problem 51 51
Computer Software Problem 11 11
Low Readings 10 10
Improper or Incorrect Procedure or Method 10 10
Contamination 7 7
Electrical /Electronic Property Problem 7 7
Leak/Splash 5 5
Alarm Not Visible 4 4
Insufficient Information 3 3
Device Contamination with Chemical or Other Material 3 3
Failure to Read Input Signal 2 2
Sparking 2 2
Mechanical Problem 2 2
Output Problem 2 2
Erratic Results 2 2
Data Problem 2 2
No Apparent Adverse Event 2 2
Arcing 2 2
Arcing of Electrodes 2 2
Unintended Electrical Shock 1 1
Non Reproducible Results 1 1
Failure to Transmit Record 1 1
Smoking 1 1
Material Integrity Problem 1 1
Failure to Clean Adequately 1 1
Battery Problem 1 1
Positioning Failure 1 1
Failure to Power Up 1 1
Use of Device Problem 1 1
Misassembly During Maintenance/Repair 1 1
Incorrect Measurement 1 1
Power Problem 1 1
Coagulation in Device or Device Ingredient 1 1
Nonstandard Device 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 397 737
Insufficient Information 31 195
Exposure to Body Fluids 2 2
Non specific EKG/ECG Changes 1 1
High Blood Pressure/ Hypertension 1 1
Electric Shock 1 1
Hypersensitivity/Allergic reaction 1 1
Hemolysis 1 1
Nausea 1 1
Bone Fracture(s) 1 1
Reaction to Medicinal Component of Device 1 1
Chills 1 1
Fever 1 1
Chest Pain 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 1 1
Shaking/Tremors 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
Headache 1 1

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