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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 1

MDR Year MDR Reports MDR Events
2018 23 23
2019 25 25
2020 31 31
2021 22 22
2022 26 26
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 64 64
Low Test Results 57 57
Incorrect Or Inadequate Test Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
High Readings 2 2
Non Reproducible Results 2 2
Use of Device Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 63 63
No Clinical Signs, Symptoms or Conditions 48 48
No Consequences Or Impact To Patient 16 16
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 Roche Diagnostics Corporation II Apr-13-2019
4 Roche Diagnostics Operations, Inc. III Oct-16-2019
5 Siemens Healthcare Diagnostics, Inc. II Mar-20-2020
6 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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