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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 7
2023 11 12
2024 11 11
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 21 21
Non Reproducible Results 19 21
Incorrect Measurement 4 4
Low Test Results 4 4
Material Integrity Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Chemical Problem 1 1
Output 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 39 41
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
2 Ortho-Clinical Diagnostics, INc. II Sep-21-2023
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