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TPLC
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show TPLC since
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Device
radioimmunoassay, human growth hormone
Product Code
CFL
Regulation Number
862.1370
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
2
2
2017
7
7
2018
10
10
2019
2
2
2020
2
2
2021
2
2
2022
6
6
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Human Factors Issue
10
10
Adverse Event Without Identified Device or Use Problem
8
8
Low Test Results
8
8
High Test Results
7
7
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Labelling, Instructions for Use or Training Problem
4
4
Product Quality Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Output Problem
1
1
Insufficient Information
1
1
Non Reproducible Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
20
20
No Clinical Signs, Symptoms or Conditions
12
12
Insufficient Information
2
2
No Consequences Or Impact To Patient
2
2
Hormonal Imbalance
2
2
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
May-11-2011
2
Beckman Coulter Inc.
II
Sep-28-2010
3
Siemens Healthcare Diagnostics, Inc.
II
Sep-16-2016
4
Tosoh Bioscience Inc
II
Jun-05-2018
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