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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device fibrinogen and fibrin split products, antigen, antiserum, control
Regulation Description Fibrinogen/fibrin degradation products assay.
Product CodeDAP
Regulation Number 864.7320
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAGNOSTICA STAGO
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low Test Results 22
Unable to Obtain Readings 14
Adverse Event Without Identified Device or Use Problem 10
High Test Results 6
Incorrect, Inadequate or Imprecise Resultor Readings 6
False Positive Result 6
Incorrect Or Inadequate Test Results 5
False Negative Result 2
Off-Label Use 2
Use of Device Problem 2
Failure to Calibrate 1
Test Strip 1
High Readings 1
Insufficient Information 1
Use of Incorrect Control Settings 1
Device Displays Incorrect Message 1
Total Device Problems 81

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics Inc II Jan-07-2016

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