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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antibody igm,if, cytomegalovirus virus
Regulation Description Cytomegalovirus serological reagents.
Product CodeLKQ
Regulation Number 866.3175
Device Class 2

Device Problems
Device Ingredient or Reagent Problem 27
Incorrect Or Inadequate Test Results 15
Incorrect, Inadequate or Imprecise Result or Readings 8
Adverse Event Without Identified Device or Use Problem 7
False Negative Result 5
False Positive Result 4
Total Device Problems 66

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Oct-27-2016

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