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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 1
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 10 10
2018 7 7
2019 14 14
2020 3 3
2021 4 4
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 15 15
Output Problem 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Improper or Incorrect Procedure or Method 3 3
Use of Device Problem 2 2
Detachment Of Device Component 2 2
False Negative Result 2 2
False Positive Result 2 2
Insufficient Information 2 2
Data Problem 2 2
Device Handling Problem 1 1
Packaging Problem 1 1
Break 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Component Falling 1 1
Contamination 1 1
Defective Component 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
High Readings 1 1
Activation, Positioning or SeparationProblem 1 1
Device Markings/Labelling Problem 1 1
Installation-Related Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Operating System Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 14 14
Viral Infection 5 5
No Known Impact Or Consequence To Patient 5 5
Test Result 5 5
No Clinical Signs, Symptoms or Conditions 5 5
No Code Available 3 3
Sexually Transmitted Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Burn(s) 1 1
Eye Injury 1 1
Patch Test, Abnormal Results Of 1 1
No Information 1 1
Injury 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

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