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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
radioimmunoassay, follicle-stimulating hormone
Product Code
CGJ
Regulation Number
862.1300
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
1
1
2017
2
2
2018
1
1
2019
1
1
2020
3
3
2021
2
2
2022
1
1
2023
3
3
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
5
5
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Premature Separation
2
2
Material Split, Cut or Torn
1
1
Incorrect Or Inadequate Test Results
1
1
Low Test Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7
7
No Known Impact Or Consequence To Patient
3
3
No Patient Involvement
3
3
No Code Available
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Applied Medical Resources Corp
II
Jan-07-2013
2
BioMerieux SA
II
Jun-29-2018
3
Ortho Clinical Diagnostics Inc
II
Oct-03-2018
4
Ortho-Clinical Diagnostics, Inc
II
May-18-2022
5
PerkinElmer Health Sciences, Inc.
III
Dec-16-2016
6
Siemens Healthcare Diagnostics, Inc
III
Sep-19-2012
7
Tosoh Bioscience Inc
II
Jun-05-2018
8
Universal Meditech Inc.
II
Oct-23-2023
9
bioMerieux, Inc.
II
Dec-28-2021
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