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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
Product CodeDHX
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DISGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 14 14
2021 11 11
2022 12 12
2023 16 16
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 31 31
Low Test Results 29 29
No Apparent Adverse Event 9 9
Non Reproducible Results 7 7
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Incorrect Measurement 2 2
False Negative Result 1 1
Mechanical Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 51
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 6 6
No Code Available 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1
Missing Value Reason 1 1

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