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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device system, test, immunological, antigen, tumor
Product CodeMOI
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 5 5
2020 11 11
2021 16 16
2022 16 16
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 22 22
Low Test Results 13 13
No Apparent Adverse Event 10 10
Incorrect, Inadequate or Imprecise Result or Readings 4 4
High Readings 2 2
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
No Known Impact Or Consequence To Patient 14 14
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
3 Siemens Healthcare Diagnostics, Inc. II May-04-2018
4 Tosoh Bioscience Inc II Jun-05-2018
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