Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 13 23

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 294 578
Incorrect, Inadequate or Imprecise Result or Readings 191 229
False Positive Result 103 138
Adverse Event Without Identified Device or Use Problem 54 54
Defective Device 15 15
Improper or Incorrect Procedure or Method 15 15
Defective Component 11 11
Computer Software Problem 6 6
Non Reproducible Results 5 13
Alarm Not Visible 4 4
Leak/Splash 3 3
Device Displays Incorrect Message 3 3
Patient-Device Incompatibility 3 3
Naturally Worn 3 3
Insufficient Information 3 3
Data Problem 3 3
Failure to Power Up 2 2
Output Problem 2 2
Component Missing 2 2
Failure to Read Input Signal 2 2
Mechanical Problem 2 4
Contamination 2 2
Positioning Failure 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Break 1 1
Circuit Failure 1 1
Coagulation in Device or Device Ingredient 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Incorrect Measurement 1 1
Image Display Error/Artifact 1 1
Excess Flow or Over-Infusion 1 1
Smoking 1 1
Inadequate or Insufficient Training 1 1
Use of Device Problem 1 1
Failure to Deliver 1 1
Failure to Obtain Sample 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Compatibility Problem 1 1
Material Twisted/Bent 1 1
Sparking 1 1
Failure to Clean Adequately 1 1
Misassembly During Maintenance/Repair 1 1
Device Handling Problem 1 1
Missing Test Results 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 299 435
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
No Information 3 3
Injury 3 3
No Patient Involvement 3 3
Fever 3 3
Hemolysis 2 2
Hemorrhage/Bleeding 2 2
No Code Available 2 2
Unspecified Tissue Injury 1 1
Reaction to Medicinal Component of Device 1 1
Electric Shock 1 1
Hematuria 1 1
Hyperbilirubinemia 1 1
Hypoxia 1 1
Laceration(s) 1 1
Nausea 1 1
Pneumonia 1 1
Rash 1 1
Respiratory Distress 1 1
Tachycardia 1 1
Chills 1 1
Bone Fracture(s) 1 1
Headache 1 1
Hearing Loss 1 1
Anxiety 1 1
Airway Obstruction 1 1
Exposure to Body Fluids 1 1

-
-