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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diazo colorimetry, bilirubin
Regulation Description Bilirubin (total or direct) test system.
Product CodeCIG
Regulation Number 862.1110
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 22 22
2022 26 26
2023 34 34
2024 39 39
2025 52 52
2026 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 80 80
Low Test Results 77 77
Non Reproducible Results 35 35
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Output Problem 4 4
Unable to Obtain Readings 4 4
Insufficient Device Problem Information 3 3
Incorrect Measurement 1 1
Use of Device Problem 1 1
Signal Artifact/Noise 1 1
False Negative Result 1 1
False Positive Result 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 199 199
Hyperbilirubinemia 1 1
No Consequences Or Impact To Patient 1 1
Insufficient Information 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, INc. II Sep-21-2023
2 Siemens Healthcare Diagnostics, Inc. II Sep-06-2024
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