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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzymatic method, ammonia
Product CodeJIF
Regulation Number 862.1065
Device Class 1


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 3 3
2016 4 4
2017 7 7
2018 1 1
2019 1 1
2020 1 1
2021 1 1
2022 2 2
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 12 12
Low Test Results 7 7
Incorrect Or Inadequate Test Results 4 4
Non Reproducible Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Visual Prompts will not Clear 2 2
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12 12
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Apr-16-2012
2 RANDOX LABORATORIES, LTD. II Sep-14-2020
3 Sekisui Diagnostics P.E.I. Inc. II Jan-23-2017
4 Sentinel CH SpA II Oct-26-2015
5 Siemens Healthcare Diagnostics, Inc. II Oct-11-2018
6 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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