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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
Product CodeCIG
Regulation Number 862.1110
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 25 25
2020 31 31
2021 22 22
2022 26 26
2023 37 37
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 83 83
Low Test Results 65 65
Non Reproducible Results 10 10
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Use of Device Problem 1 1
False Negative Result 1 1
False Positive Result 1 1
Incorrect Measurement 1 1
High Readings 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 104 104
No Known Impact Or Consequence To Patient 51 51
No Consequences Or Impact To Patient 5 5
No Patient Involvement 1 1
Test Result 1 1
Insufficient Information 1 1
Hyperbilirubinemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
2 Ortho-Clinical Diagnostics II Aug-24-2020
3 Ortho-Clinical Diagnostics, INc. II Sep-21-2023
4 Roche Diagnostics Corporation II Apr-13-2019
5 Roche Diagnostics Operations, Inc. III Oct-16-2019
6 Siemens Healthcare Diagnostics, Inc. II Mar-20-2020
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