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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, immunological, antigen, tumor
Product CodeMOI
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 11 11
2021 16 16
2022 16 16
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 27 27
Low Test Results 13 13
No Apparent Adverse Event 10 10
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Non Reproducible Results 3 3
High Readings 2 2
Imprecision 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
No Known Impact Or Consequence To Patient 13 13
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc II Sep-03-2021
2 Siemens Healthcare Diagnostics, Inc. II Aug-29-2022
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