TPLC - Total Product Life Cycle

• Device: radioimmunoassay, thyroid-stimulating hormone
• Regulation Description: Thyroid stimulating hormone test system.
• Product Code: JLW
• Regulation Number: 862.1690
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	11
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	2
BAYER
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
BIOMERIEUX
	SUBSTANTIALLY EQUIVALENT	1
Bio-Rad Laboratories
	SUBSTANTIALLY EQUIVALENT	9
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	3
DADE BEHRING
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTIC PRODUCTS
	SUBSTANTIALLY EQUIVALENT	8
DIASORIN
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	2
EASTMAN KODAK
	SUBSTANTIALLY EQUIVALENT	1
Nichols Institute Diagnostics
	SUBSTANTIALLY EQUIVALENT	3
OLYMPUS
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
ORGANON-TEKNIKA
	SUBSTANTIALLY EQUIVALENT	1
ORTHO-CLINICAL
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	2
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
SCANTIBODIES
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Low test results	35
High test results	23
Incorrect or inadequate test results	19
Incorrect or inadequate result	2
High Readings	2
Malfunction	1
Output, low	1
Total Device Problems	83

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	0	1	0	2	0
Class III	1	0	0	0	0	0	1

Recalls
Manufacturer		Recall Class	Date Posted
1	PerkinElmer LAS, Inc	II	Jan-11-2012
2	Perkinelmer	II	Aug-01-2012
3	Siemens Healthcare Diagnostics	III	Jan-07-2013
4	Siemens Healthcare Diagnostics, Inc.	II	Nov-24-2010
5	ThyroTec Inc	III	Mar-22-2007