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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, prolactin (lactogen)
Product CodeCFT
Regulation Number 862.1625
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 6 6
2017 18 18
2018 27 27
2019 12 12
2020 20 20
2021 23 23
2022 29 29
2023 28 28
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 130 130
Low Test Results 34 34
Incorrect Or Inadequate Test Results 11 11
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Incorrect Measurement 7 7
Non Reproducible Results 5 5
Insufficient Information 2 2
Leak/Splash 1 1
Separation Failure 1 1
Unclear Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 97 97
No Known Impact Or Consequence To Patient 53 53
No Consequences Or Impact To Patient 29 29
No Code Available 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Apr-20-2011
2 Ortho Clinical Diagnostics Inc II Oct-03-2018
3 Ortho-Clinical Diagnostics, Inc II May-18-2022
4 Siemens Healthcare Diagnostics, Inc III Sep-19-2012
5 Siemens Healthcare Diagnostics, Inc. II May-05-2017
6 Tosoh Bioscience Inc II Jun-05-2018
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