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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device photometric method, ammonia
Product CodeJID
Regulation Number 862.1065
Device Class 1

MDR Year MDR Reports MDR Events
2014 9 9
2015 40 40
2016 10 10
2017 8 8
2018 6 6
2019 13 13
2020 26 26
2021 19 19
2022 12 12
2023 26 26
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 108 108
Low Test Results 44 44
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Incorrect Or Inadequate Test Results 9 9
High Readings 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Low Readings 2 2
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 76 76
No Clinical Signs, Symptoms or Conditions 74 74
No Consequences Or Impact To Patient 15 15
No Information 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Nov-15-2013
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