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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device azo dye, calcium
Regulation Description Calcium test system.
Product CodeCJY
Regulation Number 862.1145
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 24 24
2022 17 17
2023 29 29
2024 34 34
2025 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 99 99
Low Test Results 58 58
Incorrect, Inadequate or Imprecise Result or Readings 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 164 164
No Known Impact Or Consequence 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 Aug-15-2025
3 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
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