TPLC - Total Product Life Cycle

• Device: radioimmunoassay, testosterones and dihydrotestosterone
• Product Code: CDZ
• Regulation Number: 862.1680
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER INC.
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIASORIN INC.
	SUBSTANTIALLY EQUIVALENT	1
IMMUNODIAGNOSTIC SYSTEMS LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMMUNOTECH S.R.O.
	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
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	34	34
Non Reproducible Results	7	7
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Incorrect Measurement	5	5
Low Test Results	4	4
Output Problem	2	2
High Readings	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Appropriate Term/Code Not Available	1	1
Unexpected Therapeutic Results	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	24
No Code Available	10	10
No Consequences Or Impact To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Insufficient Information	2	2
Nausea	1	1
Malaise	1	1
Headache	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	DRG Instruments GmbH	II	Aug-05-2019
2	DRG International, Inc.	III	Aug-15-2024
3	Qualigen Inc	II	Apr-06-2020
4	Siemens Healthcare Diagnostics, Inc.	II	Dec-02-2022