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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent, borrelia serological reagent
Product CodeLSR
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX SA
  SUBSTANTIALLY EQUIVALENT 2
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 3
EUROIMMUN US
  SUBSTANTIALLY EQUIVALENT 2
EUROIMMUN US, INC.
  SUBSTANTIALLY EQUIVALENT 1
GOLD STANDARD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 9
ID-FISH TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TRINITY BIOTECH
  SUBSTANTIALLY EQUIVALENT 2
VIRAMED BIOTECH AG
  SUBSTANTIALLY EQUIVALENT 5
ZEUS SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
ZEUS SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 2
ZEUS SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 53 53
2015 25 25
2016 10 10
2017 9 9
2018 4 4
2019 15 15
2020 7 7
2021 4 4
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 74 74
Incorrect, Inadequate or Imprecise Result or Readings 23 23
False Positive Result 17 17
Incorrect Or Inadequate Test Results 9 9
Insufficient Information 5 5
Therapeutic or Diagnostic Output Failure 3 3
Device Operates Differently Than Expected 3 3
Appropriate Term/Code Not Available 2 2
Improper or Incorrect Procedure or Method 2 2
Product Quality Problem 1 1
Unexpected Therapeutic Results 1 1
Material Integrity Problem 1 1
Protective Measures Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 37 37
No Consequences Or Impact To Patient 26 26
Misdiagnosis 25 25
Disability 24 24
No Code Available 13 13
Pain 10 10
Complaint, Ill-Defined 10 10
Fatigue 8 8
Cognitive Changes 7 7
Rash 6 6
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 5 5
Malaise 5 5
Ambulation Difficulties 4 4
Arthritis 4 4
Unspecified Infection 4 4
Weakness 4 4
Neurological Deficit/Dysfunction 4 4
Headache 4 4
Inflammation 3 3
Bacterial Infection 3 3
No Information 3 3
Memory Loss/Impairment 3 3
Dizziness 3 3
Neuropathy 3 3
Sleep Dysfunction 3 3
Nausea 2 2
Emotional Changes 2 2
Cyst(s) 2 2
Respiratory Distress 2 2
Inadequate Pain Relief 2 2
Immunodeficiency 2 2
Joint Disorder 2 2
Confusion/ Disorientation 2 2
Sweating 2 2
Fever 2 2
Tingling 2 2
Arthralgia 2 2
Pneumonia 2 2
Burning Sensation 2 2
Chills 2 2
Diarrhea 2 2
Muscle Spasm(s) 2 2
Irritability 1 1
Loss of Vision 1 1
Meningitis 1 1
Sore Throat 1 1
Ulcer 1 1
Tissue Damage 1 1
Ulceration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Innominata Dba Genbio II Mar-08-2013
2 bioMerieux, Inc. II Dec-28-2021
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