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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search Show TPLC since Back To Search Results
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
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 229
False Positive Result 109
Mechanical Problem 87
High Test Results 47
Incorrect, Inadequate or Imprecise Result or Readings 42
No Apparent Adverse Event 25
False Negative Result 15
Insufficient Information 9
Low Test Results 6
Device Issue 5
Incorrect Or Inadequate Test Results 2
Device Operational Issue 2
Low Readings 1
Human Factors Issue 1
Power Problem 1
Total Device Problems 581

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Jun-12-2018

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