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U.S. Department of Health and Human Services

Class 2 Device Recall Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System

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  Class 2 Device Recall Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System see related information
Date Initiated by Firm April 03, 2008
Date Posted September 21, 2008
Recall Status1 Terminated 3 on November 29, 2011
Recall Number Z-2386-2008
Recall Event ID 48186
510(K)Number K060256  
Product Classification Hexokinase, glucose - Product Code CFR
Product Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
Code Information Unicel DxC 600i with Peristaltic Pumps with Serial Numbers above 22349820 ; Unicel Dxl 600 Peristaltic Pumps with Serial Numbers of 22965501 and above
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall		 The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A Product Corrective Action (PCA) letter with attached Fax-Back Customer Response form was mailed on April 16, 2008 via US Postal mail to all affected customers with Access and Access 2 Immunoassay Systems, Synchron LXi 725 Systems and UniCel DxC 600i Systems. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump Mfg. No. 01-00772205 with a SN higher than 2234980. A toll free Customer Technical Support telephone was included in the letter. After further investigation by the firm, an Updated PCA letter with attached Fax-Back Customer Response form was mailed on June 30, 2008 via US Postal mail to include all customers with the following products: UniCel Dxl 800 and DxC 880i Systems with pump manufacturing number (Mfg.) of 01-010341-1 and serial number (SN) 22454201 and above, and UniCel Dxl 600 Systems with a pump Mfg. No. A24468 and SN of 22965501. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump SN referenced. If you have questions, contact Customer Technical Support at 1-800-854-3633.
Quantity in Commerce 694 Worldwide; 656 in US & 38 in Canada total for all products
Distribution Nationwide, and in Canada
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 = CFR and Original Applicant = BECKMAN COULTER, INC.
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