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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device system, test, vitamin d
Product CodeMRG
Regulation Number 862.1825
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER INC
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 75 75
2019 38 38
2020 10 10
2021 15 15
2022 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 107 107
Non Reproducible Results 31 31
Low Test Results 9 9
Incorrect Or Inadequate Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Incorrect Measurement 3 3
High Readings 3 3
Low Readings 3 3
Unable to Obtain Readings 2 2
Device Damaged Prior to Use 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 90 90
No Known Impact Or Consequence To Patient 34 34
No Clinical Signs, Symptoms or Conditions 24 24
No Patient Involvement 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Dec-22-2018
2 R & D Systems, Inc. III Nov-09-2018
3 Roche Diagnostics Corporation II Jul-08-2018
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