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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
2020 46 47
2021 54 60
2022 44 44
2023 66 66
2024 73 73
2025 83 109

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 329 341
False Positive Result 28 49
Non Reproducible Results 6 7
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Low Test Results 4 4
Incorrect Measurement 2 2
Appropriate Term/Code Not Available 2 2
Off-Label Use 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 310 336
No Known Impact Or Consequence To Patient 41 42
Insufficient Information 9 26
No Consequences Or Impact To Patient 7 7
No Code Available 2 2
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 Bio-Rad Laboratories, Inc. II Sep-18-2020
5 Siemens Healthcare Diagnostics, Inc II May-24-2021
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