Class 2 Device Recall UniCel DxH 800 Coulter Cellular Analysis System

• Date Initiated by Firm: February 11, 2011
• Date Posted: May 09, 2011
• Recall Status: Terminated on September 02, 2014
• Recall Number: Z-2157-2011
• Recall Event ID: 58308
• 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 handheld barcode scanner does not read barcode labels using NW 7 symbology. Impact: Specimens with NW7 labels cannot be read by the handheld scanner.
• FDA Determined Cause: Pending
• Action: Beckman Coulter initiated a Product Corrective Action (PCA) letter with attached Recall Response Form sent via US Postal Service on February 11, 2011 to all customers who have the affected instruments. Consignees were informed of the reasons for recall, products affected and resolution for these issues would be corrected in a future release(s) for the DxH 800; but were also asked to take the following actions: If they use NW7 bar code symbiology, the labels can be read using one of the following methods: - At the single-tube presentation station (using the internal bar code scanner) - Enter the bar code information manually at the user interface of the single-tube station - Use cassette presentation. 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 800526- 7694 in the United States or Canada, or contact their local Beckman Coulter representative.
• Quantity in Commerce: 566 units
• Distribution: Worldwide Distribution - USA (nationwide) 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.