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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, testosterones and dihydrotestosterone
Product CodeCDZ
Regulation Number 862.1680
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER INC.
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOKIT, S.A.
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNODIAGNOSTIC SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNOTECH S.R.O.
  SUBSTANTIALLY EQUIVALENT 1
MONOBIND INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOENTEK USA INC.
  SUBSTANTIALLY EQUIVALENT 1
QUALIGEN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 12 12
2015 7 7
2016 5 5
2017 12 12
2018 5 5
2019 3 3
2020 12 12
2021 7 7
2022 3 3
2023 10 10
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 53 53
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Adverse Event Without Identified Device or Use Problem 8 8
Low Test Results 8 8
Non Reproducible Results 7 7
Incorrect Measurement 5 5
Incorrect Or Inadequate Test Results 4 4
Nonstandard Device 3 3
Output Problem 2 2
High Readings 2 2
Imprecision 1 1
Device Operates Differently Than Expected 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Therapeutic Results 1 1
Improper Chemical Reaction 1 1
False Positive Result 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 26 26
No Clinical Signs, Symptoms or Conditions 24 24
No Consequences Or Impact To Patient 15 15
No Code Available 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Insufficient Information 2 2
Nausea 1 1
Misdiagnosis 1 1
Malaise 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II May-03-2017
2 Beckman Coulter Inc. II Nov-22-2010
3 DRG Instruments GmbH II Aug-05-2019
4 DRG International, Inc. III Aug-15-2024
5 Qualigen Inc II Apr-06-2020
6 Qualigen Inc II Dec-19-2013
7 Siemens Healthcare Diagnostics, Inc. II Dec-02-2022
8 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
9 Siemens Healthcare Diagnostics, Inc. II Apr-19-2017
10 Tosoh Bioscience Inc II Dec-22-2018
11 Tosoh Bioscience Inc II Jun-05-2018
12 bioMerieux, Inc. II Jun-29-2017
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