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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
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 13 13
2015 13 13
2016 3 3
2017 21 21
2018 14 14
2019 25 25
2020 19 19
2021 13 13
2022 23 23
2023 20 20
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 114 114
Low Test Results 28 28
Incorrect Or Inadequate Test Results 12 12
Non Reproducible Results 12 12
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Incorrect Measurement 3 3
Inaccurate Information 2 2
Labelling, Instructions for Use or Training Problem 2 2
False Negative Result 1 1
Suction Problem 1 1
High Readings 1 1
Low Readings 1 1
Calibration Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Improper Flow or Infusion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 76 76
No Clinical Signs, Symptoms or Conditions 62 62
No Consequences Or Impact To Patient 30 30
Insufficient Information 2 2
Test Result 1 1
No Information 1 1
No Patient Involvement 1 1
Exposure to Body Fluids 1 1
Venipuncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Mar-15-2013
2 Beckman Coulter Inc. II Sep-09-2010
3 Horiba Instruments Inc II Feb-02-2016
4 Horiba Instruments, Inc dba Horiba Medical III Nov-14-2012
5 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
6 Pointe Scientific, Inc. III Sep-16-2015
7 Pointe Scientific, Inc. II Mar-09-2010
8 Siemens Healthcare Diagnostics, Inc. II Jun-26-2020
9 Siemens Healthcare Diagnostics, Inc. II Jun-26-2015
10 Siemens Healthcare Diagnostics, Inc. II Jan-15-2012
11 Sterling Diagnostics, Inc. III Dec-29-2016
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