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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
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS
  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
2014 52 52
2015 28 28
2016 5 5
2017 7 7
2018 1 1
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 44 44
Low Test Results 22 22
Incorrect Or Inadequate Test Results 18 18
Component Falling 14 14
Incorrect, Inadequate or Imprecise Result or Readings 11 11
No Apparent Adverse Event 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Mechanical Problem 4 4
Unintended Collision 3 3
Smoking 3 3
Non Reproducible Results 3 3
Device Operates Differently Than Expected 3 3
Failure to Calibrate 2 2
High Readings 2 2
False Negative Result 2 2
False Reading From Device Non-Compliance 2 2
Imprecision 1 1
False Positive Result 1 1
Detachment Of Device Component 1 1
Nonstandard Device 1 1
Device Displays Incorrect Message 1 1
Calibration Problem 1 1
Computer Operating System Problem 1 1
Device Ingredient or Reagent Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 71 71
No Clinical Signs, Symptoms or Conditions 41 41
No Consequences Or Impact To Patient 23 23
Head Injury 4 4
Headache 2 2
Swelling 2 2
Bruise/Contusion 2 2
Erythema 1 1
Injury 1 1
No Patient Involvement 1 1
Tissue Damage 1 1
Concussion 1 1
No Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II May-12-2017
2 Siemens Healthcare Diagnostics, Inc II Sep-03-2021
3 Siemens Healthcare Diagnostics, Inc II Apr-06-2017
4 Siemens Healthcare Diagnostics, Inc II Dec-11-2012
5 Siemens Healthcare Diagnostics, Inc II Oct-28-2012
6 Siemens Healthcare Diagnostics, Inc. II Aug-29-2022
7 Siemens Healthcare Diagnostics, Inc. II May-04-2018
8 Tosoh Bioscience Inc II Jun-05-2018
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