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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
HEALTHY.IO LTD
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 56 56
2020 34 34
2021 57 57
2022 9 9
2023 43 43
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 76 76
High Test Results 67 67
Non Reproducible Results 36 36
Incorrect, Inadequate or Imprecise Result or Readings 33 33
High Readings 10 10
Insufficient Information 6 6
Appropriate Term/Code Not Available 6 6
Output Problem 3 3
Incorrect Measurement 3 3
Low Readings 2 2
Imprecision 1 1
Nonstandard Device 1 1
No Device Output 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 121 121
No Known Impact Or Consequence To Patient 54 54
No Consequences Or Impact To Patient 26 26
Insufficient Information 5 5
No Patient Involvement 3 3
Test Result 3 3
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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