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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
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
ELITECH GROUP
  SUBSTANTIALLY EQUIVALENT 1
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 1
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 3 3
2015 7 7
2016 4 4
2017 11 11
2018 23 23
2019 25 25
2020 31 31
2021 22 22
2022 26 26
2023 37 37
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 98 98
Low Test Results 81 81
Non Reproducible Results 9 9
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Incorrect Or Inadequate Test Results 6 6
High Readings 2 2
Patient-Device Incompatibility 2 2
Chemical Problem 1 1
Insufficient Information 1 1
Use of Device Problem 1 1
False Positive Result 1 1
Incorrect Measurement 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 95 95
No Known Impact Or Consequence To Patient 75 75
No Consequences Or Impact To Patient 25 25
No Code Available 2 2
Insufficient Information 1 1
Test Result 1 1
No Patient Involvement 1 1
Death, Intrauterine Fetal 1 1
Hyperbilirubinemia 1 1
Miscarriage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Apr-16-2012
2 Beckman Coulter Inc II Mar-02-2020
3 Medtest Holdings, Inc. II Jun-14-2017
4 Ortho-Clinical Diagnostics II Aug-24-2020
5 Ortho-Clinical Diagnostics II Mar-19-2014
6 Ortho-Clinical Diagnostics II Nov-15-2013
7 Ortho-Clinical Diagnostics, INc. II Sep-21-2023
8 Pointe Scientific, Inc. II Mar-05-2010
9 Pointe Scientific, Inc. III Apr-17-2009
10 Roche Diagnostics Corporation II Apr-13-2019
11 Roche Diagnostics Operations, Inc. III Oct-16-2019
12 Siemens Healthcare Diagnostics II Nov-19-2013
13 Siemens Healthcare Diagnostics, Inc. II Mar-20-2020
14 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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