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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme linked immunoabsorbent assay, toxoplasma gondii
Regulation Description Toxoplasma gondii serological reagents.
Product CodeLGD
Regulation Number 866.3780
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 38 38
2022 73 73
2023 118 118
2024 81 81
2025 91 91
2026 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 189 189
False Positive Result 184 184
False Negative Result 29 29
Low Test Results 26 26
Non Reproducible Results 11 11
Incorrect, Inadequate or Imprecise Result or Readings 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 428 428
No Consequences Or Impact To Patient 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories, Inc. II Sep-04-2025
2 bioMerieux, Inc. II Dec-28-2021
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