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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, dehydroepiandrosterone (free and sulfate)
Regulation Description Dehydroepiandrosterone (free and sulfate) test system.
Product CodeJKC
Regulation Number 862.1245
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 3 3
2018 1 1
2019 2 2
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 8 8
Leak/Splash 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Gmbh & Co. KG II May-04-2018
2 Siemens Healthcare Diagnostics, Inc. II May-04-2018
3 Tosoh Bioscience Inc II Jun-05-2018
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