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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 fibrin split products
Regulation Description Fibrinogen/fibrin degradation products assay.
Product CodeGHH
Regulation Number 864.7320
Device Class 2

Device Problems
High Test Results 24
Low Test Results 23
Incorrect, Inadequate or Imprecise Result or Readings 7
Test Strip 6
Incorrect Or Inadequate Test Results 6
Non Reproducible Results 5
High Readings 2
False Negative Result 1
Total Device Problems 74

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II Jun-06-2014
2 BBI SOLUTIONS OEM LTD II Oct-27-2016
3 Lsi Medience Corporation II Nov-21-2016

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