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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzymatic method, creatinine
Product CodeJFY
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELITECH GROUP
  SUBSTANTIALLY EQUIVALENT 1
HEALTHY.IO LTD
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEPPIM S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
TECO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
YD DIAGNOSTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 7 7
2016 16 16
2017 16 16
2018 34 34
2019 56 56
2020 34 34
2021 57 57
2022 9 9
2023 43 43
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 111 111
High Test Results 95 95
Non Reproducible Results 45 45
Incorrect, Inadequate or Imprecise Result or Readings 36 36
Adverse Event Without Identified Device or Use Problem 16 16
High Readings 12 12
Insufficient Information 7 7
Appropriate Term/Code Not Available 6 6
Incorrect Or Inadequate Test Results 6 6
Incorrect Measurement 4 4
Output Problem 3 3
Device Ingredient or Reagent Problem 2 2
Low Readings 2 2
Nonstandard Device 2 2
Chemical Problem 1 1
Imprecision 1 1
Unable to Obtain Readings 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 139 139
No Known Impact Or Consequence To Patient 110 110
No Consequences Or Impact To Patient 48 48
Insufficient Information 5 5
Test Result 3 3
No Patient Involvement 3 3
No Information 1 1
Unspecified Kidney or Urinary Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abaxis Inc II Mar-16-2010
2 Beckman Coulter Inc II Mar-02-2020
3 Beckman Coulter Inc. II May-12-2017
4 Diagnostic Chemicals, Ltd. II Sep-30-2009
5 Ortho-Clinical Diagnostics II Aug-24-2020
6 Ortho-Clinical Diagnostics III Sep-19-2018
7 Ortho-Clinical Diagnostics II Apr-23-2014
8 Ortho-Clinical Diagnostics II Nov-15-2013
9 Polymer Technology Systems, Inc. II Jun-28-2012
10 Roche Diagnostics Operations, Inc. II Jun-27-2015
11 Sentinel CH SPA II Jun-27-2017
12 Siemens Healthcare Diagnostics, Inc. II Jun-05-2020
13 Siemens Healthcare Diagnostics, Inc. II Jan-24-2020
14 Siemens Healthcare Diagnostics, Inc. II May-11-2016
15 Siemens Healthcare Diagnostics, Inc. II Sep-05-2015
16 Siemens Healthcare Diagnostics, Inc. II May-10-2011
17 Siemens Healthcare Diagnostics, Inc. II May-09-2011
18 Siemens Healthcare Diagnostics, Inc. II Sep-16-2010
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