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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
EMCYTE CORPORATION
  SE - WITH LIMITATIONS 1

MDR Year MDR Reports MDR Events
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 4 4
Detachment of Device or Device Component 3 3
Insufficient Information 2 2
Use of Device Problem 2 2
Component Missing 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Open or Close 1 1
Obstruction of Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Contamination with Body Fluid 1 1
Improper or Incorrect Procedure or Method 1 1
Burst Container or Vessel 1 1
Infusion or Flow Problem 1 1
Unintended Electrical Shock 1 1
Sparking 1 1
Noise, Audible 1 1
Crack 1 1
Incomplete or Inadequate Connection 1 1
Unexpected Shutdown 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Known Impact Or Consequence To Patient 4 4
No Patient Involvement 2 2
Death 2 2
Incomplete Induced Abortion 1 1
Injury 1 1
Electric Shock 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LW Scientific, Inc. II Mar-23-2019
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