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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
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 34 34
2021 57 57
2022 9 9
2023 43 43
2024 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 74 74
Low Test Results 68 68
Non Reproducible Results 37 37
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Insufficient Information 6 6
Appropriate Term/Code Not Available 6 6
Incorrect Measurement 5 5
Output Problem 3 3
High Readings 2 2
Low Readings 2 2
Device Markings/Labelling Problem 1 1
Material Integrity 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 157 157
No Known Impact Or Consequence To Patient 17 17
No Consequences Or Impact To Patient 12 12
Insufficient Information 5 5
Test Result 1 1
Unspecified Kidney or Urinary Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
2 Ortho-Clinical Diagnostics II Aug-24-2020
3 Siemens Healthcare Diagnostics, Inc. II Jun-05-2020
4 Siemens Healthcare Diagnostics, Inc. II Jan-24-2020
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