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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
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
2020 33 33
2021 24 24
2022 17 17
2023 29 29
2024 34 34
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 98 98
Low Test Results 63 63
Incorrect, Inadequate or Imprecise Result or Readings 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 137 137
No Known Impact Or Consequence To Patient 27 27
Test Result 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
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