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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
Product CodeLGD
Regulation Number 866.3780
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 59 59
2020 87 87
2021 38 38
2022 73 73
2023 118 118
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 188 188
High Test Results 129 129
No Apparent Adverse Event 28 28
Incorrect, Inadequate or Imprecise Result or Readings 17 17
False Negative Result 15 15
Non Reproducible Results 11 11
Low Test Results 10 10
Adverse Event Without Identified Device or Use Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 270 270
No Known Impact Or Consequence To Patient 76 76
No Consequences Or Impact To Patient 57 57
No Patient Involvement 2 2
No Code Available 2 2

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