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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device radioimmunoassay, testosterones and dihydrotestosterone
Product CodeCDZ
Regulation Number 862.1680
Device Class 1


Premarket Reviews
ManufacturerDecision
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNODIAGNOSTIC SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMMUNOTECH S.R.O.
  SUBSTANTIALLY EQUIVALENT 1
MONOBIND INC.
  SUBSTANTIALLY EQUIVALENT 1
QUALIGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 12 12
2018 5 5
2019 3 3
2020 12 12
2021 7 7
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 32 32
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Adverse Event Without Identified Device or Use Problem 4 4
Low Test Results 2 2
High Readings 1 1
Unexpected Therapeutic Results 1 1
Device Issue 1 1
Output Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 13 13
No Known Impact Or Consequence To Patient 10 10
No Clinical Signs, Symptoms or Conditions 9 9
No Consequences Or Impact To Patient 7 7
Insufficient Information 2 2
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II May-03-2017
2 DRG Instruments GmbH II Aug-05-2019
3 Qualigen Inc II Apr-06-2020
4 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
5 Siemens Healthcare Diagnostics, Inc. II Apr-19-2017
6 Tosoh Bioscience Inc II Dec-22-2018
7 Tosoh Bioscience Inc II Jun-05-2018
8 bioMerieux, Inc. II Jun-29-2017
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