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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, human growth hormone
Product CodeCFL
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 1 1

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
High Test Results 7 7
Low Test Results 7 7
Labelling, Instructions for Use or Training Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Improper or Incorrect Procedure or Method 2 2
Product Quality Problem 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 11 11
No Consequences Or Impact To Patient 2 2
Hormonal Imbalance 2 2
Insufficient Information 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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