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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 radioimmunoassay, testosterones and dihydrotestosterone
Regulation Description Testosterone test system.
Product CodeCDZ
Regulation Number 862.1680
Device Class 1


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMMUNODIAGNOSTIC SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 7 7
2022 3 3
2023 10 10
2024 11 11
2025 18 18
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 35 35
Non Reproducible Results 15 15
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Incorrect Measurement 9 9
Low Test Results 8 8
Output Problem 1 1
Insufficient Information 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Insufficient Information 2 2
Nausea 1 1
Malaise 1 1
No Consequences Or Impact To Patient 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Jun-02-2025
2 DRG International, Inc. III Aug-15-2024
3 GET TESTED INTERNATIONAL AB II Dec-01-2025
4 Qualigen Inc III Jan-03-2025
5 Siemens Healthcare Diagnostics, Inc. II Dec-02-2022
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