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TPLC
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show TPLC since
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2024
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Device
alkaline picrate, colorimetry, creatinine
Product Code
CGX
Regulation Number
862.1225
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K161494
Atellica CH Creatinine_2 (Crea_2), Atellica CH Che
...
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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