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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, follicle-stimulating hormone
Regulation Description Follicle-stimulating hormone test system.
Product CodeCGJ
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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 3 3
No Code Available 2 2
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Jun-29-2018
2 Ortho Clinical Diagnostics Inc II Oct-03-2018
3 PerkinElmer Health Sciences, Inc. III Dec-16-2016
4 Tosoh Bioscience Inc II Jun-05-2018
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