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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
Product CodeCDZ
Regulation Number 862.1680
Device Class 1


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, 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
QUALIGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 25 25
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Unexpected Therapeutic Results 1 1
Low Test Results 1 1
High Readings 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 12 12
No Clinical Signs, Symptoms or Conditions 9 9
No Consequences Or Impact To Patient 7 7
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 DRG Instruments GmbH II Aug-05-2019
2 Qualigen Inc II Apr-06-2020
3 Siemens Healthcare Diagnostics, Inc. II Dec-02-2022
4 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
5 Tosoh Bioscience Inc II Dec-22-2018
6 Tosoh Bioscience Inc II Jun-05-2018
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