i-STAT PT NORMAL AND ABNORMAL CONTROL
TRININY BIOTECH PLC
MATERIAL SAFETY DATA SHEET
Name of Product: i-STAT PT Normal control and PT Abnormal control
Product Code: 50407/50408
MSDS Number: VA-0005
Written by: Nicola Flynn Date: 27 Jan. 03
PRODUCT AND COMPANY IDENTIFICATION
Product Name: I-STAT PT Normal Control Emergency Phone: Ireland: 01-837-9964
I-STAT PT Abnormal Control Belgium: (+31)30 2748888
France (+331) 40.37.04.04
Supplier Name: Trinity Biotech Plc USA 1 800-603-8076
Address: IDA Business Park
Bray, Co. Wicklow Ireland
Phone Number: + 353 1 276 9800
Fax Number: + 353 1 276 9888
COMPOSITION/INFORMATION ON COMPONENTS
Preparation/Substance: Preparation
COMPONENTS CONTRIBUTING TO THE HAZARD:
The PT normal and the PT Abnormal Control Plasma Reagents consist of human source plasma, that has
been lyophilized. It does not contain any hazardous ingredients.
HAZARD IDENTIFICATION
BIOHAZARD
WARNING STATEMENT: Each unit of human source plasma used in the preparation of this
product has been tested by FDA approved methods for the presence of antibody to Human
Immunodeficiency Virus (HIV) Type I and Type II, Hepatitis B surface antigen (HbsAg) as well as for
Hepatitis C (HCV) and found negative (not repeatedly reactive). Donors have been screened for
Creutfeldt-Jakob Disease (CJD) and now variant Creutzfeldt-Jakob Disease (NvCJD) and found
acceptable. However, no test can offer complete assurance that products derived from human blood will
not transmit infectious disease. As with all materials of human origin, this product should be handled as a
potentially infectious material. All wastes containing biological material should be properly labeled and
stored separately from other wastes. Dispose of all waste materials according to prescribed international,
national, and local regulations. Direct or repeated contact may cause irritation. May cause sensitization.
For medical diagnostic use only.
FIRST AID MEASURES
Eye and Skin contact: Immediately flush/wash thoroughly with water for 15 minutes and notify medical
personnel.
Inhalation: Not applicable.
Ingestion: Drink a moderate amount (8-12 oz.) of water and immediately notify medical personnel.
1 of 4
i-STAT PT NORMAL AND ABNORMAL CONTROL
FIRE FIGHTING MEASURES
Extinguishing Media: Use method suitable to surroundings (E.G.: water spray, carbon dioxide,
multipurpose dry chemical or halon-fire extinguisher).
Hazardous combustion products: Not known.
Special Procedures: Wear self-contained breathing apparatus and protective clothing to prevent contact
with skin and eyes.
ACCIDENTAL RELEASE MEASURES
Personal precautions: If material is released or spilled, take proper precautions to minimize exposure by
using appropriate personal protective equipment. Shut off all sources of ignition.
Cleaning Methods: Cordon off spill area and minimize the spreading of spilled material. Soak up
material with absorbent. Wash spill area thoroughly with bleach, Tween (10:1) solution or other
appropriate disinfectant.
Environmental precautions: Collect spilled material, absorbent and rinse water into suitable containers
for proper disposal in accordance with applicable waste disposal regulations. Prevent runoff into
sewers, storm drains, surface waters, and soil.
HANDLING AND STORAGE
Avoid contact with skin, eyes or clothing. Use adequate ventilation to minimize exposure. Wash
thoroughly after handling. Store at 2-8 deg C.
EXPOSURE CONTROL/PERSONAL PROTECTION
Eye, Face and Skin Protection: The choice of protection should be based on the job activity and
potential for exposure to the eyes, face and skin. Wear safety glasses with side shields or full-face
shield if eye contact is likely. Wear gloves, lab coat, or other protective overgarment if skin contact is
likely.
Respiratory Protection: When handling bulk quantities or for long durations where aerosolization of
materials is likely or material may become airborne, wear a NIOSH/MSHA-approved air-purifying
respirator.
Engineering controls: When practical, the material should be handled in enclosed or contained processes
with a properly operating laboratory hood or with other effective local exhaust ventilation.
Hygiene Measures: Wash hands immediately after handling this material (especially before eating,
drinking or smoking). Decontaminate or discard protective equipment after each use. Should
ingestion of the preparation occur, seek medical advice immediately.
PHYSICAL AND CHEMICAL PROPERTIES
This preparation consists of a lyophilized reagent (solid). Data is not currently available for the chemical
properties of the preparation as a whole.
2 of 4
i-STAT PT NORMAL AND ABNORMAL CONTROL
STABILITY AND REACTIVITY
Stability: Stable under normal conditions of use. Hazardous polymerization is not expected to occur.
Hazardous Decomposition Products: Unknown
Incompatibility: Unknown
TOXICOLOGICAL INFORMATION
Refer to section 3 for Additional Information on Health Hazards
Each unit of human source plasma used in the preparation of this product has been tested by FDA
approved methods for the presence of antibody to Human Immunodeficiency Virus (HIV) Type I and
Type II, Hepatitis B surface antigen (HbsAg) as well as for Hepatitis C (HCV) and found negative (not
repeatedly reactive). Donors have been screened for Creutfeldt-Jakob Disease (CJD) and now variant
Creutzfeldt-Jakob Disease (NvCJD) and found acceptable. However, no test can offer complete
assurance that products derived from human blood will not transmit infectious disease. As with all
materials of human origin, this product should be handled as a potentially infectious material. All wastes
containing biological material should be properly labeled and stored separately from other wastes.
Dispose of all waste materials according to prescribed international, national, and local regulations.
Direct or repeated contact may cause irritation. May cause sensitization. For medical diagnostic use only.
ECOLOGICAL INFORMATION
No data
DISPOSAL CONSIDERATIONS
Incinerate or autoclave at 121 deg C/25 deg F for at least 90 minutes. All wastes containing the material
should be properly labeled and stored separately from other waste. Dispose of waste materials according
to prescribed national and local regulations.
TRANSPORT INFORMATION
Land Transport (ADR/RID): Not regulated
Air Transport (ICAO/IATA): Not regulated
Maritime Transport (IMO-IMDG): not regulated.
REGULATORY INFORMATION
Caution 鈥? this preparation has not yet been fully tested.
OTHER INFORMATION
The above information is based on data available t us and is believed to be correct. Since the information
may be applied under conditions beyond our control and with which we may be unfamiliar, we do not
3 of 4
i-STAT PT NORMAL AND ABNORMAL CONTROL
assume any responsibility for the results of its use and all persons receiving it shall make their own
determination of the effects, properties, and protections which pertain to their particular conditions.
No representation, warranty, or guarantee, express or implie d (including a warranty of fitness or
merchantability for a particular purpose), is made with respect to the material, the accuracy of this
information, the results to be obtained from the sue thereof, or the hazards connected with the use of the
material. Caution should be used in the handling and use of the material.
4 of 4
|