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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
Product CodeCJY
Regulation Number 862.1145
Device Class 2


Premarket Reviews
ManufacturerDecision
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 29 29
2020 33 33
2021 24 24
2022 17 17
2023 29 29
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 74 74
Low Test Results 64 64
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 82 82
No Known Impact Or Consequence To Patient 54 54
No Consequences Or Impact To Patient 2 2
Test Result 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories Ltd. II Feb-15-2019
2 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
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