TPLC - Total Product Life Cycle

• Device: enzyme linked immunoabsorbent assay, rubella
• Product Code: LFX
• Regulation Number: 866.3510
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIO-RAD LABORATORIES
	SUBSTANTIALLY EQUIVALENT	1
DIAMEDIX CORP.
	SUBSTANTIALLY EQUIVALENT	1
DIASORIN, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	13	13
2015	15	15
2016	47	47
2017	10	10
2018	24	24
2019	16	16
2020	21	21
2021	13	13
2022	13	13
2023	7	7
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	42	42
Device Ingredient or Reagent Problem	33	33
False Positive Result	25	25
False Negative Result	22	22
Low Test Results	17	17
Incorrect, Inadequate or Imprecise Result or Readings	15	15
Adverse Event Without Identified Device or Use Problem	11	11
No Apparent Adverse Event	11	11
Incorrect Or Inadequate Test Results	6	6
Non Reproducible Results	4	4
Low Readings	1	1
Use of Device Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	93	93
No Consequences Or Impact To Patient	49	49
No Clinical Signs, Symptoms or Conditions	32	32
No Patient Involvement	5	5
Chemical Exposure	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bio-Rad Laboratories	II	May-19-2011
2	Bio-Rad Laboratories	III	Mar-02-2010
3	BioCheck Inc	II	Mar-11-2011
4	Diasorin Inc.	III	Mar-02-2010
5	Meridian Bioscience Inc	II	Nov-17-2011
6	Siemens Healthcare Diagnostics Inc.	II	Mar-10-2010
7	Siemens Healthcare Diagnostics, Inc.	II	Oct-13-2016
8	bioMerieux, Inc.	II	Dec-28-2021