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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device differential rate kinetic method, cpk or isoenzymes
Product CodeJHS
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
SENTINEL CH. SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 3 3
2016 1 1
2017 1 1
2018 6 6
2019 6 6
2020 13 13
2021 4 4
2022 3 3
2023 12 12
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 23 23
Low Test Results 21 21
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Non Reproducible Results 4 4
Output Problem 2 2
Incorrect Or Inadequate Test Results 2 2
Incorrect Measurement 1 1
Use of Device Problem 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 26 26
No Clinical Signs, Symptoms or Conditions 22 22
No Consequences Or Impact To Patient 5 5
Renal Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Jan-05-2021
2 Ortho-Clinical Diagnostics II May-08-2020
3 Ortho-Clinical Diagnostics II Nov-15-2013
4 Siemens Healthcare Diagnostics, Inc II Oct-15-2018
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