TPLC - Total Product Life Cycle

• Device: radioimmunoassay, parathyroid hormone
• Regulation Description: Parathyroid hormone test system.
• Product Code: CEW
• Regulation Number: 862.1545
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER
	SUBSTANTIALLY EQUIVALENT	1
Bio-Rad Laboratories
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTIC PRODUCTS
	SUBSTANTIALLY EQUIVALENT	10
DIASORIN
	SUBSTANTIALLY EQUIVALENT	3
Nichols Institute Diagnostics
	SUBSTANTIALLY EQUIVALENT	13
ORTHO-CLINICAL
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	3
SCANTIBODIES
	SUBSTANTIALLY EQUIVALENT	10
SIEMENS
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
High test results	44
No Known Device Problem	31
Device ingredient or reagent issue	21
Low test results	11
Incorrect or inadequate test results	10
Mechanical issue	2
Output issue	2
No code available	1
Device handling issue	1
Incorrect or inadequate result	1
False positive result	1
Total Device Problems	125

Recalls
	2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017
Class I	0	0	0	0	0	0	0	0	0	0	0
Class II	1	0	0	2	0	1	1	0	0	1	1
Class III	0	0	0	0	0	0	1	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Dec-09-2010
2	Beckman Coulter Inc.	II	Oct-20-2010
3	ORTHO-CLINICAL DIAGNOSTICS	II	Dec-23-2016
4	Roche Diagnostics Corp.	II	May-16-2007
5	Siemens Healthcare Diagnostics, Inc	III	Nov-06-2013
6	Siemens Healthcare Diagnostics, Inc	II	Jun-06-2013
7	Siemens Healthcare Diagnostics, Inc	II	Mar-07-2012
8	Siemens Healthcare Diagnostics, Inc.	II	Jan-09-2017