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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
Regulation Description Vitamin D test system.
Product CodeMRG
Regulation Number 862.1825
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNOSTICS INC.,
  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
2020 10 10
2021 15 15
2022 13 13
2023 22 24
2024 32 32
2025 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 87 88
Non Reproducible Results 70 72
Low Test Results 21 21
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Incorrect Measurement 6 6
Insufficient Information 5 5
Low Readings 5 5
High Readings 4 4
Material Integrity Problem 3 4
Chemical Problem 2 2
Signal Artifact/Noise 2 2
No Device Output 2 2
Degraded 1 2
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1
Failure to Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 105 107
No Consequences Or Impact To Patient 14 14
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
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