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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
Regulation Description Treponema pallidum treponemal test reagents.
Product CodeLSR
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 3
EUROIMMUN US, INC.
  SUBSTANTIALLY EQUIVALENT 1
GOLD STANDARD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 7
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TRINITY BIOTECH
  SUBSTANTIALLY EQUIVALENT 2
VIRAMED BIOTECH AG
  SUBSTANTIALLY EQUIVALENT 2
ZEUS SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 2
ZEUS SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 9 9
2018 4 4
2019 15 15
2020 7 7
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 23 23
Incorrect, Inadequate or Imprecise Resultor Readings 14 14
Unexpected Therapeutic Results 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 8 8
No Patient Involvement 5 5
No Clinical Signs, Symptoms or Conditions 3 3
Misdiagnosis 3 3
Disability 2 2
Bacterial Infection 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Dec-28-2021
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