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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ion-specific, chloride
Product CodeCGZ
Regulation Number 862.1170
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2020 3 3
2022 5 5
2023 10 10
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 10 10
Low Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Non Reproducible Results 6 6
Output Problem 2 2
Misassembly During Maintenance/Repair 1 1
Material Integrity Problem 1 1
Degraded 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II May-08-2019
2 Ortho-Clinical Diagnostics II Nov-01-2019
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