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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
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K223503  Access 25(OH) Vitamin D Total
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNODIAGNOSTIC SYSTEMS LTD
  SUBSTANTIALLY EQUIVALENT 1
IMMUNODIAGNOSTIC SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOENTEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 18 18
2016 14 14
2017 21 21
2018 75 75
2019 38 38
2020 10 10
2021 15 15
2022 13 13
2023 22 22
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 153 153
Non Reproducible Results 55 55
Low Test Results 26 26
Incorrect Or Inadequate Test Results 17 17
Adverse Event Without Identified Device or Use Problem 15 15
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Incorrect Measurement 5 5
High Readings 3 3
Low Readings 3 3
Unable to Obtain Readings 2 2
Device Damaged Prior to Use 2 2
Material Integrity Problem 2 2
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Degraded 1 1
Chemical 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 104 104
No Known Impact Or Consequence To Patient 73 73
No Clinical Signs, Symptoms or Conditions 60 60
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 Qualigen Inc II Sep-07-2017
3 R & D Systems, Inc. III Nov-09-2018
4 Roche Diagnostics Corporation II Jul-08-2018
5 Siemens Healthcare Diagnostics, Inc II Nov-11-2016
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