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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
Regulation Description Treponema pallidum treponemal test reagents.
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
2021 54 60
2022 44 44
2023 66 66
2024 73 73
2025 112 138
2026 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 339 351
False Positive Result 38 58
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Non Reproducible Results 6 7
Appropriate Term/Code Not Available 2 2
Incorrect Measurement 2 2
Off-Label Use 1 1
High Test Results 1 1
Low Test Results 1 1
Output Problem 1 1
Device Handling Problem 1 1
Component Misassembled 1 1
Unclear Information 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 375 401
Insufficient Information 10 27
No Known Impact Or Consequence To Patient 4 4
Localized Skin Lesion 1 12
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 Siemens Healthcare Diagnostics, Inc II May-24-2021
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