TPLC - Total Product Life Cycle

• Device: calibrator, secondary
• Regulation Description: Calibrator.
• Product Code: JIT
• Regulation Number: 862.1150
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	4
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	1
BAYER
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER
	SUBSTANTIALLY EQUIVALENT	7
BIONOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	1
DADE BEHRING
	SUBSTANTIALLY EQUIVALENT	27
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	2
Diagnostic Chemicals Ltd.
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTICA STAGO
	SUBSTANTIALLY EQUIVALENT	1
EMD
	SUBSTANTIALLY EQUIVALENT	3
FISHER
	SUBSTANTIALLY EQUIVALENT	1
GENZYME CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
Nichols Institute Diagnostics
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	1
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	3
ORTHO-CLINICAL
	SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION	4
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	14
SIEMENS
	SUBSTANTIALLY EQUIVALENT	4

Device Problems
No Information	1
Total Device Problems	1

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	0	0	0	2	5	0
Class III	1	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Oct-10-2012
2	Beckman Coulter Inc.	II	Mar-20-2012
3	Beckman Coulter Inc.	II	May-20-2011
4	Beckman Coulter Inc.	II	May-10-2011
5	Bio-Rad Laboratories Inc	II	Jan-25-2007
6	Immunodiagnostics Systems Ltd	II	Oct-10-2012
7	Ortho-Clinical Diagnostics	II	Feb-07-2012
8	Siemens Healthcare Diagnostics, Inc.	II	Jan-11-2012
9	Wako Chemicals USA, Inc.	III	Jul-12-2007