October, 2013

re: Material Safety Infonnation

To Whom It May Concern:

As per Occupational Safety and Health Authority (OSHA) Standard (29 CFR § 1910.1200), Material Safety Data Sheets (MSDS) are required for products containing a hazardous material greater than or equal to I % of the composition, or a carcinogen greater or equal to 0.1 % of the composition.

The following products are considered non-hazardous by this standard:

Heparin Assay - Red Cartridge Catalog Number 304-01 POR Heparin Assay - Yellow Cartridge Catalog Number 304-02POR Heparin Assay - Tan Cartridge Catalog Number 304-03POR Heparin Assay - Silver Cartridge Catalog Number 304-04POR Heparin Assay - Blue Cartridge Catalog Number 304-05POR Heparin Assay - Green Cartridge Catalog Number 304-06POR Heparin Assay - Orange Cartridge Catalog Number 304-07POR Heparin Assay - Gold Cartridge Catalog Number 304-08POR Heparin Assay - White Cartridge Catalog Number 304-09POR Heparin Assay - Purple Cartridge Catalog Number 304-1 OPOR Heparin Assay - Black Cartridge Catalog Number 304-11 POR Heparin Dose Response Cartridge Catalog Number 304-20POR HR ACT Cartridge Catalog Number 304-30 RedlY ellow Control Catalog Number 306-0 I POR Tan/Silver Control Catalog Number 306-02POR Blue/Gold Control Catalog Number 306-03POR Green/White Control Catalog Number 306-04POR Orange Control Catalog Number 306-05POR Purple/Black Control Catalog Number 306-09POR LR-ACT Cartridge Catalog Number 402-01 RACT Cartridge Catalog Number 402-02 HR-ACT Cartridge Catalog Number 402-03 HTC Cartridge Catalog Number 402-07 CLOTtrac CWB Control Catalog Number 550-01 CLOTtrac HR Control Catalog Number 550-07 CLOTtrac HR Abnonnal Control Catalog Number 550-08 CLOTtrac LR Abnonnal Control Catalog Number 550-09 CLOTtrac RACT Abnonnal Control Catalog Number 550-10 Calcium Chloride Catalog Number 550-11 CLOTtrac HTC Control Catalog Number 550-12 CLOTtrac Control Pack Catalog Number 550-13 HEPline Kit Catalog Number 313-50 Proficiency Kits: Catalog Numbers 550-90, 550-91, 55091A (CTl-Ol thru CTl-06 and CTS-Ol thru CTS-06),

55091B (CTl-Ol thruCTl- 06 and CTS-Ol thru CTS- 06) POC14-01, 55092, 55093, 55095, 55096, 55097

Specifics on controls:

Medtronic controls have no human derived components, thus there is no risk from human infectious diseases. The transmission of infectious material of sheep origin is extremely remote. The sheep used to manufacture Medtronic Perfusion System coagulation controls are a controlled flock of sheep that are maintained strictly for the purpose of providing blood for the manufacture of controls. These sheep are drawn under controlled conditions, their diet controlled, and each individual sheep carries an identification ill. The sheep's general physical conditions are monitored regularly, and the coagulation characteristics and hematocrits monitored.

During the processing of the blood into various controls, the cellular components are isolated and then run through a process that fixes the cell membrane. This process inactivates viral, bacterial, or parasitic contaminants that could be present in the cellular fraction. The cells are then washed and added back to the plasma. Coagulation controls do not undergo any sterilization procedures, since sterilization would destroy the coagulation activity of the control. Fresh, frozen, and lyophilized whole blood and plasma are used on nearly a daily basis since 1984. During this period of time, there have been no adverse affects reported or identified with respect to any biological interactions with sheep blood.

Please refer to the product package inserts for information regarding ingredients and proper handling. If you have any further questions or for any additional information, please call me at (303) 840-4012.

Sincerely,

~z(k Suzan Dillon Manufacturing Manager Medtronic Structural Heart

2

----Haematologic

echnologies Inc.

Dear Carol Baumeister,

As a CAP supplier, we annually review SDS (MSDS) compliance for all Proficiency Testing , (PT) material supplied to CAP. CAP was provided SDS for all products manufactured for Proficiency Testing for the 2013 calendar year. As our products will not change for the 2014 calendar year, from the 2013 calendar year, the SDS for our products supplied will also not change.

CAP Surveys - MSDS 2014

ADP: Mailing:

PF-A PF-B

Epinephrine: PF-A PF-B

Specimen:

AGST-Ol AGST-04

AGST-02 AGST-03

Calcium Chloride: PLTM-A PLTM-B

CT5-A CT5-B

POC14-A POC14-B

CACL-Ol CACL-02

CT5-CCI CTS-CC2

POC14-CC POC14-CC

Sodium Heparin: (BD Vacutainer re£# 367871) PLTM-A NAHEP-Ol PLTM-B NAHEP-02

Sodium Citrate: (BD Vacutainer re£# 366415) PF1-A NACIT-01 PF-A NACIT-0'1 PLTM-A NACIT-01

Lot #

AGST-LAI AGST-LA4

AGST-LA2 AGST-LA3

CACL-LA1, CACL-LAI

CT5-L17 CT5-LA7

CT5-LA7 CT5-LA7

HEP-LA1 HEP-LA1

NACIT-LA1 NACIT-LAI NACIT-LA1

Haematologic Technologies, Inc., 57 River Road, Unit 1021, Essex Jct., VT 05452 USA

Tel: 802-878-1777 FAX: 802-878-1776 Email: hti@haemtech.com Web: www.haemtech.com

Sodium Citrate Cont. : PFl-B NACIT-02 NACIT-LAI PF-B NACIT-02 NACIT-LAI PLTM-B NACIT-02 NACIT-LAl'

Sodium Chloride 0.85% (Normal Saline): PFl-A PFl-02 PFl-LAl PFl-B PFl-03 PFl-LAl

PF-A PF-02 PF-LAI PF-B PF-03 PF-LAI

PLTM-A PLTM-02 PLTM-LAI PLTM-B PLTM-03 PLTM-LAI

Tirofiban Hydrochloride: PFl-A PFl-Ol PFl-LA2 PFl-B PFl-04 PFl-LA2

PF-A PF-Ol PF-LA2 PF-B PF-04 PF-LA2

PLTM-A PLTM-Ol PLTM-LA2 PLTM-B PLTM-04 PLTM-LA2

If you have any questions, please do not hesitate to contact me.

Michael Shaw Senior ASQ CQT/Production Leader-Blood Tube Division

Haematologic Technologies, Inc., 57 River Road, Unit 1021, Essex JcL, VT 05452 USA

Tel: 802-878-1777 FAX: 802-878-1776 Email: hti@haemtech.com Web: www.haemtech.com