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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device azo dye, calcium
Product CodeCJY
Regulation Number 862.1145
Device Class 2


Premarket Reviews
ManufacturerDecision
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 21 21
2019 29 29
2020 33 33
2021 24 24
2022 17 17
2023 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 78 78
Low Test Results 65 65
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
High Readings 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 71 71
No Clinical Signs, Symptoms or Conditions 69 69
No Consequences Or Impact To Patient 6 6
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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