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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
Product CodeCGX
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  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 20 20
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 92 92
Low Test Results 20 20
Non Reproducible Results 17 17
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Incorrect Measurement 3 3
Output Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Inaccurate Information 2 2
Pressure 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
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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