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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ion specific, calcium
Product CodeJFP
Regulation Number 862.1145
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT POINT OF CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 3 3
2017 2 2
2018 5 5
2019 6 6
2020 6 6
2022 6 6
2023 2 2
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 10 10
High Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Non Reproducible Results 5 5
Incorrect Measurement 4 4
Incorrect Or Inadequate Test Results 3 3
Output Problem 2 2
Insufficient Information 1 1
Misassembly During Maintenance/Repair 1 1
Environmental Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 14 14
No Clinical Signs, Symptoms or Conditions 12 12
No Known Impact Or Consequence To Patient 8 8
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Radiometer America Inc II Jun-16-2011
2 Roche Diagnostics Operations, Inc. II Feb-08-2021
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