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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


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 10 10
2015 2 2
2016 1 1
2017 2 2
2018 19 19
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 31 31
Low Test Results 15 15
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Non Reproducible Results 7 7
Incorrect Or Inadequate Test Results 4 4
Output Problem 2 2
Misassembly During Maintenance/Repair 1 1
Material Integrity Problem 1 1
Degraded 1 1
False Device Output 1 1
False Reading From Device Non-Compliance 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Product Quality 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 15 15
No Known Impact Or Consequence To Patient 14 14
No Patient Involvement 11 11

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II May-08-2019
2 OPTI Medical Systems, Inc II Jun-14-2011
3 OPTI Medical Systems, Inc III Mar-11-2010
4 Ortho-Clinical Diagnostics II Nov-01-2019
5 Ortho-Clinical Diagnostics III Sep-17-2018
6 Ortho-Clinical Diagnostics III Sep-14-2018
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