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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 system, test, carcinoembryonic antigen
Regulation Description Tumor-associated antigen immunological test system.
Product CodeDHX
Regulation Number 866.6010
Device Class 2

Device Problems
Low Test Results 26
Adverse Event Without Identified Device or Use Problem 15
High Test Results 13
No Apparent Adverse Event 11
False Negative Result 11
Incorrect, Inadequate or Imprecise Result or Readings 7
Incorrect Or Inadequate Test Results 4
Mechanical Problem 4
Insufficient Information 2
Tube 2
Device Subassembly 1
Filter 1
Probe 1
Non Reproducible Results 1
Device Ingredient Or Reagent 1
Washer 1
Total Device Problems 101

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Nov-06-2015
2 Siemens Healthcare Diagnostics, Inc. II May-04-2018
3 Tosoh Bioscience Inc II Jun-05-2018

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