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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)
Regulation Description Prolactin (lactogen) test system.
Product CodeCFT
Regulation Number 862.1625
Device Class 1

MDR Year MDR Reports MDR Events
2016 6 6
2017 18 18
2018 27 27
2019 12 12
2020 20 20
2021 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 69 69
Low Test Results 20 20
Incorrect Or Inadequate Test Results 11 11
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Incorrect Measurement 1 1
Separation Failure 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 52 52
No Consequences Or Impact To Patient 29 29
No Clinical Signs, Symptoms or Conditions 19 19
No Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Oct-03-2018
2 Siemens Healthcare Diagnostics, Inc. II May-05-2017
3 Tosoh Bioscience Inc II Jun-05-2018
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