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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxH 800 Coulter Cellular Analysis System

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  Class 2 Device Recall UniCel DxH 800 Coulter Cellular Analysis System see related information
Date Initiated by Firm February 11, 2011
Date Posted May 10, 2011
Recall Status1 Terminated 3 on November 21, 2012
Recall Number Z-2172-2011
Recall Event ID 58234
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/
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Clair K. ODonovan, Ph.D.
Manufacturer Reason
for Recall
The recall was initiated because: Specimen tubes may fall out of a Type A cassette (PN A53551, kit of 20) when the analyzer inverts the cassette in the mixing station, or when an operator manually inverts a cassette The impact: - Specimen tubes may fall out of cassettes and be misplaced inside the instrument - Specimen tubes may break upon impact, causing possible biohazard exposure - Patien
FDA Determined
Cause 2
Action Beckman Coulter initiated a Product Corrective Action (PCA) letter with attached Recall Response Form being sent via US Postal Service on February 11, 2011 to all customers who have the affected instruments. Customers 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: -Periodically inspect the mix station drip tray for misplaced tubes that may have fallen from the cassette. - Periodically examine the Type A cassettes to determine if the expandable grippers (clips) within the lavender-colored insert are stuck in the open position (tubes will be loose). Consignees were told to contact their Beckman Coulter representative for assistance with questionable grippers. - Clean any spills according to their laboratory standard operating procedures. 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 the 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 (Nationwide)and to 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, & 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.