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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
2018 6 6
2019 6 6
2020 13 13
2021 4 4
2022 3 3
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 20 20
Low Test Results 11 11
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Use of Device Problem 1 1
Incorrect Measurement 1 1
No Apparent Adverse Event 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 21 21
No Clinical Signs, Symptoms or Conditions 12 12
No Consequences Or Impact To Patient 2 2

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