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
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
1.  K182521  FastPack IP Sex Hormone Binding Globulin Immunoass ...
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	Dec-02-2022
5	Siemens Healthcare Diagnostics, Inc.	II	Jul-13-2018
6	Siemens Healthcare Diagnostics, Inc.	II	Apr-19-2017
7	Tosoh Bioscience Inc	II	Dec-22-2018
8	Tosoh Bioscience Inc	II	Jun-05-2018
9	bioMerieux, Inc.	II	Jun-29-2017