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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device biuret (colorimetric), total protein
Regulation Description Total protein test system.
Product CodeCEK
Regulation Number 862.1635
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 1 1
2023 12 12
2024 33 33
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 39 39
Non Reproducible Results 9 9
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Output Problem 3 3
High Test Results 3 3
No Apparent Adverse Event 2 2
Material Integrity Problem 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 51
No Known Impact Or Consequence To Patient 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Jan-12-2021
2 Siemens Healthcare Diagnostics, Inc. II Sep-08-2025
3 Siemens Healthcare Diagnostics, Inc. II Sep-06-2024
4 Siemens Healthcare Diagnostics, Inc. II Aug-29-2023
5 Siemens Healthcare Diagnostics, Inc. II Oct-28-2021
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