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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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

MDR Year MDR Reports MDR Events
2021 15 15
2022 13 13
2023 22 24
2024 32 32
2025 29 29
2026 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 97 98
Non Reproducible Results 88 90
Low Test Results 32 32
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Incorrect Measurement 8 8
Low Readings 5 5
Insufficient Device Problem Information 5 5
High Readings 4 4
Material Integrity Problem 3 4
Chemical Problem 2 2
No Device Output 2 2
Signal Artifact/Noise 2 2
Contamination 1 1
Degraded 1 2
Output Problem 1 1
Failure to Calibrate 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 133 135
No Consequences Or Impact To Patient 4 4
Insufficient Information 1 1

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