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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 test, epithelial ovarian tumor-associated antigen (ca125)
Product CodeLTK
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 15 15
2018 8 8
2019 15 15
2020 5 5
2021 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 21 21
Adverse Event Without Identified Device or Use Problem 9 9
Low Test Results 7 7
No Apparent Adverse Event 5 5
Incorrect Or Inadequate Test Results 4 4
Non Reproducible Results 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 39 39
No Clinical Signs, Symptoms or Conditions 3 3
Misdiagnosis 2 2
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc II Apr-24-2018
2 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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