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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
Regulation Description Calcium test system.
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

MDR Year MDR Reports MDR Events
2020 6 6
2022 6 6
2023 2 2
2024 8 8
2025 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Low Test Results 16 16
Non Reproducible Results 11 11
Output Problem 8 8
High Test Results 7 7
Incorrect Measurement 6 6
Imprecision 1 1
Unable to Obtain Readings 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
No Consequences Or Impact To Patient 6 6

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