TPLC - Total Product Life Cycle

• Device: kit, test,alpha-fetoprotein for testicular cancer
• Product Code: LOJ
• Regulation Number: 866.6010
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
	SUBSTANTIALLY EQUIVALENT	1
ORTHO CLINICAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	3	3
2015	3	3
2016	5	5
2017	9	9
2018	18	18
2019	14	14
2020	1	1
2021	5	5
2022	1	1
2023	3	3
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Apparent Adverse Event	18	18
High Test Results	16	16
Low Test Results	12	12
Adverse Event Without Identified Device or Use Problem	12	12
Off-Label Use	4	4
Non Reproducible Results	4	4
Incorrect Or Inadequate Test Results	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
False Positive Result	1	1
False Reading From Device Non-Compliance	1	1
Mechanical Problem	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	35	35
No Consequences Or Impact To Patient	14	14
No Clinical Signs, Symptoms or Conditions	11	11
No Code Available	2	2
Insufficient Information	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	II	Sep-18-2009
2	BioCheck Inc	II	Mar-11-2011
3	ORTHO-CLINICAL DIAGNOSTICS	III	Jul-08-2016
4	Tosoh Bioscience Inc	II	Jun-05-2018