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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
2019 25 25
2020 19 19
2021 13 13
2022 23 23
2023 20 20
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 84 84
Low Test Results 14 14
Non Reproducible Results 13 13
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Inaccurate Information 2 2
Labelling, Instructions for Use or Training Problem 2 2
Incorrect Measurement 2 2
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 65 65
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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