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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alkaline picrate, colorimetry, creatinine
Regulation Description Creatinine test system.
Product CodeCGX
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 25 25
2020 19 19
2021 13 13
2022 23 23
2023 19 19
2024 32 32
2025 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 101 101
Low Test Results 32 32
Non Reproducible Results 28 28
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Output Problem 3 3
Incorrect Measurement 3 3
Labelling, Instructions for Use or Training Problem 2 2
Inaccurate Information 2 2
Pressure Problem 1 1
Mechanical Problem 1 1
Material Integrity Problem 1 1
High Readings 1 1
Unable to Obtain Readings 1 1
Improper Flow or Infusion 1 1
Low Readings 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 119 119
No Known Impact Or Consequence To Patient 37 37
No Consequences Or Impact To Patient 8 8
Insufficient Information 2 2
Exposure to Body Fluids 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
2 Siemens Healthcare Diagnostics, Inc. II Jun-26-2020
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