Class 2 Device Recall UniCel DxH Coulter Cellular Analysis System

• Date Initiated by Firm: February 11, 2011
• Date Posted: May 05, 2011
• Recall Status: Terminated on September 02, 2014
• Recall Number: Z-2148-2011
• Recall Event ID: 58307
• 510(K)Number: K081930
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029; The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).
• Code Information: All Serial Numbers are affected
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• Manufacturer Reason for Recall: The recall was initiated because: The DxH 800 may fail to meet the carryover specification for NRBC% when the WBC is greater than 50 X 10 to the 3rd power cells/micro L (50 X 10 to the 9th power cells/L) Beckman Coulter indicated the NRBC% carryover is unlikely to have clinical impact.
• FDA Determined Cause: Other
• Action: Beckman Coulter sent an Urgent Product Correction letter, dated February 11, 2011, via US Postal Service to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were informed the issues would be corrected in a future release(s) for the DxH 800. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with their laboratory staff and retain this notification as part of their Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, consignees were told to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.
• Quantity in Commerce: 566 units
• Distribution: Worldwide Distribution - USA including AL, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Australia ,Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, and the United Kingdom
• 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 = GKZ and Original Applicant = BECKMAN COULTER, INC.