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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
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 2 2
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 4 4
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 6 6
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 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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