Product Labeling and Packaging Information
Beckman Coulter is updating the appearance of our product labeling in order to standardize labeling across the company and maintain compliance with changing global regulatory requirements.
Over the next few months, you may notice changes to the labeling on your Beckman Coulter products as a result of this initiative.
Some labeling changes may include:
- The use of harmonized symbols instead of text
- European Union (EU) Instructions for Use (IFU) part number and revision added to product package, as applicable
- Glossary of symbols in the IFU or a separate document
Packaging Bar Code Changes for Beckman Coulter Products
To meet customer and regulatory requirements, Beckman Coulter 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all the necessary information on the bar code label without increasing packaging, some of the linear bar codes have been replaced by 2D GS1 codes. Click here for a list of the impacted products.
PLEASE 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.
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 Beckman Coulter 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
- What is the timeline for the change to the impacted products? When will customers need to have the capability to read the new bar codes?
Beckman Coulter began adding 2D GS1 Data Matrix bar codes to product packages in 2015. After September 24, 2016, some products will have only 2D GS1 Data Matrix bar codes. Click here for a list of products that will have only 2D GS1 Data Matrix bar codes. Customers needing to read the bar codes of these products must have the capability to do so on or before September 24, 2016.
- What drove the adoption of the new bar code standard?
The added GS1 bar codes comply with unique device identifier (UDI) requirements mandated by the FDA to adequately identify medical devices throughout their distribution and use.
- What type of reader will be required to read the new bar code?
Any 2D-headed scanner will work. The type of device required will depend on the specific systems of the facility and should be defined by their receiving department.
- Does Beckman Coulter have any recommendations for bar code-reading systems?
Beckman Coulter does not make recommendations on bar code-reading systems.
- Does Beckman Coulter provide bar code-reading systems or subsidize customers in purchasing them?
Beckman Coulter does not provide bar code-reading systems or subsidize customers in purchasing them.
- Will this bar code change affect the reagent bar codes used when operating Beckman Coulter instruments?
The reagent pack, bottle and cartridge bar code labels are not changing. The change only affects the product packaging or box.
- Are there any plans to change the reagent bar codes in the near future?
No, there are not any plans to change the reagent bar codes in the near future.
- If a facility does not use a bar code-reading system, is there any action the laboratory needs to take?
If the facility currently does not use a bar code-reading system, then no action is required.
- What information is in the 2D GS1 DataMatrix bar code that isn’t in the linear one?
The date of manufacture and Global Trade Item Number (GTIN) are in the new bar code. The product item number is not in the GS1 bar code.
- Where can I get more information about the new bar code change?
Information regarding this new bar code change may be found at www.beckmancoulter.com/GS1
- Will there be any delay in the laboratory receiving products if it does not upgrade to the current bar code-reading system?
To avoid any delay in receiving products, the laboratory should consult with the facility’s receiving department to ensure necessary upgrades are in place.
- If the laboratory upgrades its bar code-scanning system, can it still read the linear bar codes?
The laboratory needs to have a system that is able to read both types of bar codes.
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 hazardous 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 in to 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. Beckman Coulter is committed to maintaining a high level of compliance and diligently working towards meeting the GHS requirements.
What is the Impact of the GHS?
As Beckman Coulter implements the GHS, customers will see changes to Beckman Coulter labeling, Safety Data Sheets (formerly MSDS), and Instructions For Use.
Beckman Coulter products may also be reclassified in respect to the GHS hazard classification. Reclassification could result in the following actions:
- Some previously hazardous products will change to non-hazardous; Beckman Coulter will remove any hazard symbols and phrases from labeling
- Some previously hazardous products will remain hazardous; Beckman Coulter will add the GHS label elements as required
- Some previously non-hazardous products will change to hazardous; Beckman Coulter will add a signal word, hazard and precautionary statements, and hazard pictograms to labeling as required
- The GHS hazard pictogram(s) with a red border will be added, and the orange hazard symbol and EU classification information will be removed
- Signal word such as "DANGER" or "WARNING" will be added per the GHS
- Risk phrases will be replaced by Hazard statements
- Safety phrases will be replaced by Precautionary statements
- Hazardous products may state new hazardous ingredients per the GHS classification
- Addition of hazards not included within the GHS may be included as a pictogram or statement
Instructions For Use
- Instructions For Use will change to align with labeling as mentioned in the label section
- Instructions For Use will have both previous hazard classification and new GHS hazard classification information during the period of transition
Safety Data Sheets
- Section 2 of the Safety Data Sheet will display hazard classification and information per the GHS
- Section 15 of the Safety Data Sheet will display previous hazard classification
- Addition of hazards not included within the GHS may be included as a symbol or phrase
For further detailed information on the GHS, we encourage you to visit the Reference section at the bottom of this page. There you will find direct links to agency sites which provide in-depth information on the GHS, and all related requirements.
Customer Notification Documents
- United nations http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html
- OSHA GHS HAZCOM standard https://www.osha.gov/dsg/hazcom/index.html
- European regulation http://www.echa.europa.eu/web/guest/regulations/clp/legislation
- Canada http://www.ccohs.ca/oshanswers/chemicals/ghs.html
- REACH 1907/2006 http://echa.europa.eu/web/guest/regulations/reach/legislation