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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sirolimus test system
Regulation Description Sirolimus test system.
Definition Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.
Product CodeNRP
Regulation Number 862.3840
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2016 7 7
2017 1 1
2018 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 7 7
High Test Results 4 4
Low Test Results 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II May-04-2018
2 Siemens Healthcare Diagnostics, Inc. II May-04-2018
3 Siemens Healthcare Diagnostics, Inc. II May-10-2016
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