Analytical reagents falsely represented as manufactured by Cygnus Technologies may significantly compromise the intended quality control of a given analytical method. Furthermore, use of counterfeited or otherwise adulterated reagents puts the end user as risk from legal or disciplinary action by various regulatory agencies. Ensuring that products are authentic and in compliance with U.S. and International Regulations is a shared responsibility between the manufacturer and the end user. It is important for you to have practices in place to detect falsely labeled or adulterated analytical reagents. Below are procedures providing general recommendations that can be implemented at various levels within your organization to insure you do not put your organization at risk from use of counterfeit reagents. These recommendations will facilitate compliance with U.S. FDA requirements for releasing drug products based on results from kits manufactured by Cygnus Technologies, Inc.
To the Attention of Purchasing Agents - Authentic Cygnus products should be purchased directly from Cygnus Technologies or through approved distributors. Products purchased from any other source are likely inferior counterfeits and not manufactured or quality controlled to meet intended applications. Qualifying the source from whom you obtain your products is the best way to ensure the accuracy of Cygnus analytical products. To help avoid counterfeits, Cygnus has a consistent pricing policy. Offers to sell our products at "very low discount prices" are very likely not authentic Cygnus products and may be adulterated.
To the Attention of Quality Assurance, Quality Control and Laboratory Personnel - Cygnus packaging and labeling is very consistent and has unique aspects that can be easily authenticated by us or by you. If you have questions or suspicions about a given product you need only contact our Technical Services Department at [email protected]. Any products that have been repacked, rebottled or relabeled are likely to be counterfeit, contaminated, adulterated or otherwise compromised by inappropriate storage temperatures, importation delays and transport causing circumstances that could affect product safety and/or deterioration. Know the details of the product you purchase from Cygnus Technologies. Have a product description available and verify that the product you have received conforms to this description in terms of packaging, bottle size, volume and labeling. All kits from Cygnus come in a unique custom plastic box, which preserves the quality of the contents. This packaging minimizes the absorption of moisture, which may cause deterioration of the microtiter plates. If you have received a kit in a cardboard/paper or otherwise different looking box than shown on our website, it did not come from Cygnus.
We are committed to global efforts in pursuing stricter laws and regulations regarding counterfeiting, to thwart such activity that is detrimental to consumer safety and the intended use of our products by biopharmaceutical manufacturers.