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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
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 46 46
2021 54 54
2022 44 44
2023 66 66
2024 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 232 232
False Positive Result 18 18
Low Test Results 10 10
Incorrect, Inadequate or Imprecise Result or Readings 3 3
No Apparent Adverse Event 3 3
Appropriate Term/Code Not Available 2 2
Off-Label Use 1 1
Non Reproducible Results 1 1
Unclear Information 1 1
High Test Results 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 203 203
No Known Impact Or Consequence To Patient 45 45
No Consequences Or Impact To Patient 12 12
Insufficient Information 4 4
No Code Available 2 2
Exposure to Body Fluids 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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