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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 2 2

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
Circuit Failure 4 4
Defective Component 4 4
Failure to Align 4 4
Use of Device Problem 4 4
Fire 3 3
Improper or Incorrect Procedure or Method 3 3
Crack 3 3
Detachment of Device or Device Component 3 3
Noise, Audible 2 2
Failure To Service 2 2
Component Falling 2 2
Device Displays Incorrect Message 2 2
Electrical /Electronic Property Problem 2 2
Device Stops Intermittently 2 2
Overheating of Device 2 2
Electrical Shorting 2 2
Misconnection 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Expiration Date Error 2 2
Insufficient Information 2 2
Unintended Electrical Shock 2 2
Device Contamination with Body Fluid 2 2
Burst Container or Vessel 2 2
Sparking 2 2
Device Slipped 2 2
Leak/Splash 2 2
Component Missing 1 1
Obstruction of Flow 1 1
Failure to Power Up 1 1
Device Maintenance Issue 1 1
Infusion or Flow Problem 1 1
Patient Data Problem 1 1
Material Integrity Problem 1 1
Delivered as Unsterile Product 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Separation 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 5 5
Eye Injury 4 4
Death 2 2
No Code Available 2 2
Injury 2 2
Hearing Impairment 1 1
Incomplete Induced Abortion 1 1
Hearing Loss 1 1
Nausea 1 1
Venipuncture 1 1
Bone Fracture(s) 1 1
Physical Entrapment 1 1
Headache 1 1
Thromboembolism 1 1
Bruise/Contusion 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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