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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
Product CodeCJE
Regulation Number 862.1050
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 1 1
2022 6 6
2023 11 11
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 10 10
High Test Results 9 9
Low Test Results 4 4
Material Integrity Problem 2 2
Chemical Problem 1 1
Computer Software Problem 1 1
Incorrect Measurement 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
No Consequences Or Impact To Patient 2 2

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