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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


Premarket Reviews
ManufacturerDecision
SIEMENS HEALTHCARE DISGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 22 22
2017 7 7
2018 20 20
2019 12 12
2020 14 14
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 27 27
High Test Results 25 25
No Apparent Adverse Event 17 17
Adverse Event Without Identified Device or Use Problem 9 9
Non Reproducible Results 3 3
Incorrect Or Inadequate Test Results 2 2
False Negative Result 1 1
False Reading From Device Non-Compliance 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 47 47
No Code Available 15 15
No Consequences Or Impact To Patient 15 15
No Clinical Signs, Symptoms or Conditions 7 7
Missing Value Reason 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II May-04-2018
2 Tosoh Bioscience Inc II Jun-05-2018
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