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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 1

MDR Year MDR Reports MDR Events
2020 87 87
2021 38 38
2022 73 73
2023 118 118
2024 81 81
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 208 208
High Test Results 148 148
False Negative Result 18 18
No Apparent Adverse Event 16 16
Low Test Results 12 12
Non Reproducible Results 11 11
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Adverse Event Without Identified Device or Use Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 345 345
No Known Impact Or Consequence To Patient 46 46
No Consequences Or Impact To Patient 31 31

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Dec-28-2021
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