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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
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 6 6
2022 6 6
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Low Test Results 6 6
High Test Results 4 4
Non Reproducible Results 4 4
Incorrect Measurement 4 4
Misassembly During Maintenance/Repair 1 1
Output Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
No Consequences Or Impact To Patient 7 7
No Known Impact Or Consequence To Patient 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Feb-08-2021
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