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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 1

MDR Year MDR Reports MDR Events
2018 7 7
2019 14 14
2020 3 3
2021 4 4
2022 12 12
2023 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 16 16
False Positive Result 14 14
False Negative Result 8 8
Output Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Improper or Incorrect Procedure or Method 3 3
Product Quality Problem 2 2
Detachment Of Device Component 2 2
Contamination 2 2
Break 1 1
Component Falling 1 1
Off-Label Use 1 1
High Readings 1 1
Activation, Positioning or Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Installation-Related Problem 1 1
Operating System Becomes Nonfunctional 1 1
Use of Device Problem 1 1
Packaging Problem 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Unspecified Infection 14 14
Viral Infection 5 5
Test Result 5 5
Eye Injury 2 2
Patch Test, Abnormal Results Of 1 1
No Code Available 1 1
Sexually Transmitted Infection 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Injury 1 1
No Known Impact Or Consequence To Patient 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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