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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fibrinogen and fibrin split products, antigen, antiserum, control
Product CodeDAP
Regulation Number 864.7320
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 9 9
2015 38 38
2016 20 20
2017 17 17
2018 5 5
2019 9 9
2020 11 11
2021 7 7
2022 30 30
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 32 32
Unable to Obtain Readings 26 26
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Incorrect Or Inadequate Test Results 13 13
False Positive Result 12 12
Nonstandard Device 11 11
High Test Results 10 10
Adverse Event Without Identified Device or Use Problem 10 10
False Negative Result 5 5
Use of Device Problem 4 4
Off-Label Use 2 2
Smoking 1 1
Use of Incorrect Control/Treatment Settings 1 1
False Reading From Device Non-Compliance 1 1
Failure to Calibrate 1 1
High Readings 1 1
Device Displays Incorrect Message 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Insufficient Information 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 54 54
No Known Impact Or Consequence To Patient 45 45
No Clinical Signs, Symptoms or Conditions 39 39
No Code Available 5 5
No Patient Involvement 3 3
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Insufficient Information 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. I Jul-06-2012
2 BioMerieux SA II Aug-14-2014
3 Siemens Healthcare Diagnostics Inc II Jan-07-2016
4 Siemens Healthcare Diagnostics, Inc. III Aug-28-2012
5 bioMerieux, Inc. II Dec-28-2021
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