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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxH 800 Analyzer

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  Class 2 Device Recall UniCel DxH 800 Analyzer see related information
Date Initiated by Firm October 20, 2010
Date Posted April 14, 2011
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-1980-2011
Recall Event ID 58288
510(K)Number K081930  
Product Classification UniCel DxH 800 Analyzer - Product Code GKZ
Product UniCel DxH 800 Floor Cabinet Part Number: 723335
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: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
Code Information All serial numbers, SW version 1.1.3.0
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers. IMPACT: There is potential for exposure to blood borne pathogens such as HIV, HBV, and HCV.
FDA Determined
Cause 2		 Other
Action Beckman Coulter sent an Urgent Product Corrective Action letter dated October 20, 2010, with a PCA Response Form (via US PostalService) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. This letter informed the customers about the problems identified and provided an action/resolution to this issue. Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation. Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter representative
Quantity in Commerce 422 units in total (175 in US)
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, 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 and Original Applicant = BECKMAN COULTER, INC.
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