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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, carcinoembryonic antigen
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
2018 20 20
2019 12 12
2020 14 14
2021 11 11
2022 12 12
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 34 34
No Apparent Adverse Event 17 17
High Test Results 13 13
Non Reproducible Results 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Or Inadequate Test Results 1 1
False Negative Result 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 33 33
No Clinical Signs, Symptoms or Conditions 22 22
No Consequences Or Impact To Patient 11 11
No Code Available 3 3
Missing Value Reason 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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