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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 5 5
2019 6 6
2020 6 6

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 7 7

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