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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nitrophenylphosphate, alkaline phosphatase or isoenzymes
Regulation Description Alkaline phosphatase or isoenzymes test system.
Product CodeCJE
Regulation Number 862.1050
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 6 6
2023 11 11
2024 11 11
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 17 17
Non Reproducible Results 15 15
Low Test Results 5 5
Incorrect Measurement 3 3
Material Integrity Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Chemical Problem 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, INc. II Sep-21-2023
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