Class 2 Device Recall Unicel DxH 800 Coulter Cellular Analysis System

• Date Initiated by Firm: May 09, 2011
• Date Posted: September 01, 2011
• Recall Status: Terminated on June 18, 2012
• Recall Number: Z-3125-2011
• Recall Event ID: 58705
• 510(K)Number: K081930
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: Unicel DxH 800 Coulter Cellular Analysis System Product Usage: UniCel DxH 800 Coulter Cellular Analysis System Instructions for Use PN 629743AD 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) (BF).
• Code Information: Part Number: 629029
• FEI Number: 2050012
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• Manufacturer Reason for Recall: The recall was initiated because Beckman Coulter has confirmed that the probe wash collar tubing may become stretched or trapped at the Sample Aspiration Module (SAM) during routine use of single-tube presentation station. When the tension on the tubing is severe, the tubing may not be able to return to its home state and may pull the wash collar out of alignment with the aspirate probe. The misal
• FDA Determined Cause: Pending
• Action: Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated May 11, 2011 with an attached Product Correction Response Form to all affected customers. The letter provides the customers with an explanation of the problem identified, potential impact should the problem occur and actions to be taken. The letter states that this issue will be corrected in a future hardware release. Customers were instructed to share this information with laboratory staff and retain this notification as part of Quality System documentation. If ownership or location of the analyzer(s) has been transferred to another laboratory, customers were instructed to provide a copy of the letter to that party. Customers were also asked to complete and return the enclosed Response Form within ten (10) days, so Beckman can be assured they have received this important communication. Questions concerning this notice, were directed to the Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.
• Quantity in Commerce: 680 units
• Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and 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