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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzymatic, carbon-dioxide
Product CodeKHS
Regulation Number 862.1160
Device Class 2


Premarket Reviews
ManufacturerDecision
ALFA WASSERMANN
  SUBSTANTIALLY EQUIVALENT 1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER IRELAND INC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 1
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
RANDOX LABORATORIES LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
TECO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 1 1
2016 4 4
2017 7 7
2018 15 15
2019 35 35
2020 31 31
2021 14 14
2022 10 10
2023 25 25
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 70 70
Low Test Results 64 64
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Incorrect Measurement 2 2
Incorrect Or Inadequate Test Results 2 2
Inadequate Storage 1 1
High Readings 1 1
Device Operates Differently Than Expected 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Known Impact Or Consequence To Patient 57 57
No Patient Involvement 20 20
No Consequences Or Impact To Patient 19 19
Coma 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott GmBH & Co. KG II Nov-26-2019
2 Beckman Coulter Inc. II May-18-2023
3 Ortho-Clinical Diagnostics II Nov-15-2013
4 Ortho-Clinical Diagnostics, INc. II Dec-07-2023
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