Beckman Coulter, Inc.

CLOSEOUT LETTER Beckman Coulter, Inc. MARCS-CMS 678042 — April 04, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Kevin O’Reilly Recipient Title President Beckman Coulter, Inc. Beckman Coulter Diagnostics 1000 Lake Hazeltine Drive Chaska , MN 55318-1037 United States Koreilly@DHDiagnostics.com Issuing Office: Division of Medical Device and Radiological Health Operations Central United States Secondary Issuing Offices United States Dear Mr. O’Reilly: The Food and Drug Administration has completed an evaluation of Beckman Coulter Inc.’s corrective actions in response to our Warning Letter (CMS # 678042, March 2024). Based on our evaluation, it appears that you have addressed the violations 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/ Matthew G. Hillebrenner Deputy Director Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 04/10/2025 Regulated Product(s) Medical Devices