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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
2021 1 1
2023 12 13
2024 33 33
2025 7 7
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 40 41
Non Reproducible Results 12 13
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Output Problem 3 3
High Test Results 2 2
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 55 56

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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