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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
Regulation Description Calcium test system.
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
2016 3 3
2017 24 24
2018 21 21
2019 29 29
2020 33 33
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 55 55
Low Test Results 49 49
Packaging Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
High Readings 1 1
Low Readings 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 94 94
No Consequences Or Impact To Patient 10 10
No Clinical Signs, Symptoms or Conditions 8 8
Insufficient Information 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Jul-23-2016
2 Randox Laboratories Ltd. II Feb-15-2019
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