• 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 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
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 10 10
2019 7 7
2020 4 4
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Detachment of Device or Device Component 3 3
Use of Device Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Device Expiration Issue 2 2
Material Fragmentation 2 2
Inadequate User Interface 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Burst Container or Vessel 1 1
Crack 1 1
Mechanical Problem 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Smoking 1 1
Device Stops Intermittently 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Patient Involvement 5 5
No Clinical Signs, Symptoms or Conditions 3 3
Death 2 2
Injury 2 2
Electric Shock 1 1
Incomplete Induced Abortion 1 1
No Information 1 1
No Code Available 1 1

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