Class 3 Device Recall Access 2 Immunoassay System

• Date Initiated by Firm: November 06, 2017
• Create Date: January 03, 2018
• Recall Status: Terminated on November 04, 2019
• Recall Number: Z-0310-2018
• Recall Event ID: 78613
• 510(K)Number: K060256
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
• Code Information: Serial/Lot Numbers: 801060 and 801061
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: 469-961-4941
• Manufacturer Reason for Recall: Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
• FDA Determined Cause: Device Design
• Action: An Urgent Medical Device Recall letter, dated November 6, 2017, were sent to the affected customers via mail. The letter identifies the affected device, the reason for recall, impact, and actions to be taken. The firm states that customers may continue to operate their system normally. Customers are instructed to contact Technical Support if a device on the Access 2 instrument needs alignment. The alignment tool is only to be used by the Beckman Coulter service personnel and Beckman Coulter trained biomedical engineers. A Beckman Coulter service rep will contact customers to schedule a service visit. Customers are to share this information with their staff and retain a copy of the letter. Customers are to respond via one of the ways identified. Beckman Coulter should be contacted with any questions regarding the notice.
• Quantity in Commerce: 2 units
• Distribution: Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJE