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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dna-reagents, neisseria
Product CodeLSL
Regulation Number 866.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 6 6
2017 10 10
2018 7 7
2019 14 14
2020 3 3
2021 4 4
2022 12 12
2023 23 23
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 19 19
No Apparent Adverse Event 16 16
False Negative Result 12 12
Improper or Incorrect Procedure or Method 6 6
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Output Problem 4 4
Use of Device Problem 3 3
Device Markings/Labelling Problem 3 3
Contamination 3 3
Break 2 2
Detachment Of Device Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Data Problem 2 2
Product Quality Problem 2 2
Device Handling Problem 1 1
Non Reproducible Results 1 1
Erratic Results 1 1
Operating System Becomes Nonfunctional 1 1
Packaging Problem 1 1
Component Falling 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Off-Label Use 1 1
Installation-Related Problem 1 1
Defective Component 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
High Readings 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
Unspecified Infection 14 14
No Known Impact Or Consequence To Patient 6 6
Test Result 5 5
Viral Infection 5 5
No Code Available 4 4
Injury 3 3
Eye Injury 2 2
Exposure to Body Fluids 1 1
Burn(s) 1 1
Sore Throat 1 1
Chemical Exposure 1 1
Bowel Perforation 1 1
Irritation 1 1
Blurred Vision 1 1
No Consequences Or Impact To Patient 1 1
Sexually Transmitted Infection 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patch Test, Abnormal Results Of 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cepheid II Feb-12-2018
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