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


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 16 16
2022 16 16
2023 6 6
2024 5 5
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 24 24
Low Test Results 19 19
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Non Reproducible Results 4 4
Mechanical Problem 1 1
High Readings 1 1
Imprecision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc II Sep-03-2021
2 Siemens Healthcare Diagnostics, Inc. II Aug-29-2022
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