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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

MDR Year MDR Reports MDR Events
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 22 22
Low Test Results 12 12
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Non Reproducible Results 4 4
Output Problem 2 2
No Apparent Adverse Event 1 1
Incorrect Measurement 1 1
Use of Device Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
No Known Impact Or Consequence To Patient 16 16
Renal Failure 1 1
No Consequences Or Impact To Patient 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
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