Euro Diagnostica AB

CLOSEOUT LETTER Euro Diagnostica AB MARCS-CMS 524316 — September 14, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Ronald E. Long Recipient Title CEO Euro Diagnostica AB Box 50117 Lundavagen 151 20211 Malmo, Skane Lan Sweden Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mr. Long: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS#524316] dated September 20, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Donald J. St. Pierre Acting Deputy Director for Patient Safety and Product Quality Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Content current as of: 05/09/2018 Regulated Product(s) Medical Devices