We are updating the appearance of our product labeling in order to standardize labeling across the company and maintain compliance with changing global regulatory requirements.
Some labeling changes may include:
To meet customer and regulatory requirements, we began adding two-dimensional (2D) GS1 Data Matrix bar codes to product packages in 2015. The GS1 bar codes comply with unique device identifier (UDI) requirements mandated by the FDA to adequately identify medical devices throughout their distribution and use.
To include all the necessary information on the bar code label without increasing packaging, some of the linear bar codes have been replaced by 2D GS1 codes. See a list of the impacted products ›
Note: Reading 2D bar codes may require upgrading your facility's scanning equipment in the receiving area. Please communicate this change to all appropriate individuals.
Examples:
Example of a 2D GS1 Data Matrix bar code
Example of a linear HIBC bar code
No action is required in the laboratory. The bar code changes will not affect the reagent bar codes read by Beckman Coulter instruments.
If you have any questions, please contact customer support at 1-800-854-3633 from the U.S. or Canada. Outside of North America, call +353 65 683 1170 or contact your local Beckman Coulter representative.
Frequently asked questions
Introduction
In 1992, the United Nations Conference on Environment and Development (UNCED) adopted an international mandate for a globally harmonized hazard classification and compatible labeling system. The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was first approved by the GHS Sub-Committee in 2002 (published in 2003), and has since been updated every two years. Many international systems were examined by the United Nations as the primary basis for elaboration of the GHS.
Today, the GHS provides an internationally harmonized system for classification of substances and mixtures according to their health, environmental, and physical hazards. It also harmonizes requirements for hazard communication elements, including labeling and safety data sheets. The benefits of the GHS are a common approach to classifying chemicals, as well as communicating any related hazards to consumers, workers, transport workers, and emergency responders.
Individual countries must determine if and how they will adopt the GHS. Many countries have begun adopting all or parts of the GHS by either integrating it into their current chemical laws, or by creating new laws. Government agencies in the United States (OSHA) and the European Union (ECHA) are pioneering the adoption of the GHS, and requiring that all products manufactured after June 1, 2015, use the new GHS classification and labeling criteria. We are committed to maintaining a high level of compliance and diligently working towards meeting the GHS requirements.
What is the Impact of the GHS?
As we implement the GHS, customers will see changes to our labeling, Safety Data Sheets (formerly MSDS), and Instructions For Use.
Beckman Coulter products may also be reclassified with respect to the GHS hazard classification. Reclassification could result in the following actions:
For each product that is reclassified, labels, Safety Data Sheets, and Instructions For Use will contain the updated hazardous classification information. Below is a general summary of these changes:
Product Labeling
Instructions For Use
Safety Data Sheets
For further detailed information on the GHS, see the References below. There you will find direct links to agency sites which provide in-depth information on the GHS, and all related requirements.
Downloadable content
Customer notification documents
English
