Class 2 Device Recall Beckman Coulter, AU5800 Chemistry Analyzer

• Date Initiated by Firm: July 30, 2015
• Date Posted: August 01, 2016
• Recall Status: Terminated on February 15, 2017
• Recall Number: Z-2310-2016
• Recall Event ID: 74568
• 510(K)Number: K112412
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: AU5800 Chemistry Analyzers, Reference No. A98352; The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
• Code Information: 1040016
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• Manufacturer Reason for Recall: Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.
• FDA Determined Cause: Nonconforming Material/Component
• Action: In March 2011, the material and molding process of the Coolant cup (C cup) was changed. BEC did not issue a customer notification letter, as we do not believe that a notificationletter was either warranted or of any potential use or value to our customers, because the coolant cup ( C cup ) is an internal component that only a BEC Field Service Engineer (FSE) can access and inspect  i.e., the C cup is not in a customer-accessible part of the analyzer. Thus, there are no specific actions the customer could take to inspect, identify, or mitigate the potential for a crack or leakage of the C cup. For questions regarding this recall call 714-961-4933.
• Quantity in Commerce: 2,130 units total (588 units in US)
• Distribution: Worldwide Distribution - US (nationwide (including Guam and Puerto Rico), and Internationally to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Zambia, Zimbabwe.
• 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 and Original Applicant = BECKMAN COULTER, INC.