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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

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 34 34
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 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Insufficient Information 2 2
Nausea 1 1
Malaise 1 1
Headache 1 1
No Consequences Or Impact To Patient 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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