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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nucleic acid amplification assay system, group b streptococcus, direct specimen test
Definition A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.
Product CodeNJR
Regulation Number 866.3740
Device Class 1


Premarket Reviews
ManufacturerDecision
CEPHEID
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 2 2
2022 3 3
2023 8 8
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 20 20
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Adverse Event Without Identified Device or Use Problem 2 2
False Negative Result 2 2
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19 19
Insufficient Information 4 4
Sepsis 2 2
Septic Shock 2 2
Meningitis 2 2
Pulmonary Dysfunction 1 1
No Known Impact Or Consequence To Patient 1 1
Feeding Problem 1 1
Convulsion/Seizure 1 1
Unspecified Respiratory Problem 1 1
Respiratory Distress Syndrome of Newborns 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hologic, Inc II Apr-06-2022
2 Luminex Corporation II Aug-15-2019
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