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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

MDR Year MDR Reports MDR Events
2018 14 14
2019 25 25
2020 19 19
2021 13 13
2022 23 23
2023 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 86 86
Low Test Results 13 13
Non Reproducible Results 6 6
Inaccurate Information 2 2
Labelling, Instructions for Use or Training Problem 2 2
Incorrect Measurement 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Incorrect Or Inadequate Test Results 1 1
High Readings 1 1
Low Readings 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 46
No Known Impact Or Consequence To Patient 45 45
No Consequences Or Impact To Patient 14 14
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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