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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme linked immunoabsorption assay, treponema pallidum
Product CodeLIP
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 5 5
2019 9 9
2020 46 46
2021 54 54
2022 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 122 122
False Positive Result 13 13
Low Test Results 12 12
Adverse Event Without Identified Device or Use Problem 3 3
No Apparent Adverse Event 3 3
Off-Label Use 2 2
High Test Results 1 1
Leak/Splash 1 1
Component Misassembled 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
No Known Impact Or Consequence To Patient 52 52
No Consequences Or Impact To Patient 12 12
Insufficient Information 3 3
No Code Available 2 2
Exposure to Body Fluids 1 1
Eye Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories, Inc. II May-16-2022
2 Bio-Rad Laboratories, Inc. II Mar-16-2022
3 Bio-Rad Laboratories, Inc. II Nov-16-2021
4 Bio-Rad Laboratories, Inc. II Sep-18-2020
5 Siemens Healthcare Diagnostics, Inc II May-24-2021
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