TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	51	51
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Adverse Event Without Identified Device or Use Problem	8	8
Low Test Results	6	6
Incorrect Measurement	4	4
Incorrect Or Inadequate Test Results	4	4
Non Reproducible Results	4	4
Nonstandard Device	3	3
High Readings	2	2
Output Problem	2	2
Appropriate Term/Code Not Available	1	1
Unexpected Therapeutic Results	1	1
Device Issue	1	1
Device Operates Differently Than Expected	1	1
Improper Chemical Reaction	1	1
False Positive Result	1	1
Imprecision	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	21	21
No Consequences Or Impact To Patient	15	15
No Code Available	14	14
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Malaise	1	1
Headache	1	1
Nausea	1	1
Misdiagnosis	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	Qualigen Inc	II	Apr-06-2020
5	Qualigen Inc	II	Dec-19-2013
6	Siemens Healthcare Diagnostics, Inc.	II	Dec-02-2022
7	Siemens Healthcare Diagnostics, Inc.	II	Jul-13-2018
8	Siemens Healthcare Diagnostics, Inc.	II	Apr-19-2017
9	Tosoh Bioscience Inc	II	Dec-22-2018
10	Tosoh Bioscience Inc	II	Jun-05-2018
11	bioMerieux, Inc.	II	Jun-29-2017