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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device centrifuges (micro, ultra, refrigerated) for clinical use
Product CodeJQC
Regulation Number 862.2050
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMET BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EMCYTE CORPORATION
  SE - WITH LIMITATIONS 1
HARVEST TECHNOLOGIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1
KAYLIGHT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 112 112
2015 130 130
2016 70 70
2017 31 31
2018 10 10
2019 7 7
2020 4 4
2021 1 1
2022 1 1
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 124 124
Thermal Decomposition of Device 82 82
Device Inoperable 81 81
Device Operates Differently Than Expected 78 78
Detachment Of Device Component 45 45
Charred 41 41
Material Fragmentation 35 35
Smoking 23 23
Melted 14 14
Device Emits Odor 13 13
Inadequate User Interface 12 12
Device Expiration Issue 11 11
Mechanical Problem 10 10
Difficult to Open or Close 5 5
Failure to Align 4 4
Use of Device Problem 4 4
Defective Component 4 4
Circuit Failure 4 4
Crack 3 3
Fire 3 3
Improper or Incorrect Procedure or Method 3 3
Detachment of Device or Device Component 3 3
Device Displays Incorrect Message 2 2
Sparking 2 2
Expiration Date Error 2 2
Electrical Shorting 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Noise, Audible 2 2
Leak/Splash 2 2
Overheating of Device 2 2
Electrical /Electronic Property Problem 2 2
Component Falling 2 2
Burst Container or Vessel 2 2
Device Contamination with Body Fluid 2 2
Device Slipped 2 2
Device Stops Intermittently 2 2
Misconnection 2 2
Failure To Service 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Delivered as Unsterile Product 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Low Test Results 1 1
Component Missing 1 1
Vibration 1 1
Intermittent Continuity 1 1
Unsealed Device Packaging 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Material Separation 1 1
Device Maintenance Issue 1 1
Fracture 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Incomplete or Inadequate Connection 1 1
Appropriate Term/Code Not Available 1 1
Patient Data Problem 1 1
Output Problem 1 1
Electronic Property Issue 1 1
Device Dislodged or Dislocated 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Fumes or Vapors 1 1
Separation Failure 1 1
Communication or Transmission Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 216 216
No Known Impact Or Consequence To Patient 85 85
No Consequences Or Impact To Patient 29 29
Not Applicable 12 12
No Information 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Electric Shock 4 4
Eye Injury 4 4
Death 2 2
Injury 2 2
No Code Available 2 2
Thromboembolism 1 1
Bruise/Contusion 1 1
Incomplete Induced Abortion 1 1
Physical Entrapment 1 1
Bone Fracture(s) 1 1
Headache 1 1
Hearing Impairment 1 1
Hearing Loss 1 1
Nausea 1 1
Venipuncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jul-23-2016
2 Becton Dickinson & Co. III Mar-11-2010
3 Biomet, Inc. III Apr-17-2009
4 Global Focus Marketing & Develop I Jul-27-2011
5 Iris Diagnostics II Dec-23-2014
6 LW Scientific, Inc. II Mar-23-2019
7 StatSpin, Inc., dba Iris Sample Processing II May-10-2011
8 StatSpin, Inc., dba Iris Sample Processing I Mar-04-2010
9 Terumo BCT, Inc. II Nov-16-2017
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