Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall UniCel Dxl Access Immunoassay System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall UniCel Dxl Access Immunoassay System see related information
Date Initiated by Firm July 28, 2006
Date Posted September 23, 2006
Recall Status1 Terminated 3 on March 29, 2012
Recall Number Z-1518-06
Recall Event ID 36225
510(K)Number K023764  
Product Classification Immunoassay system - Product Code JJE
Product UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer
Code Information 221208F (exp 6/9/07), 221209F(exp 6/9/07), 221210F (exp 6/10/07), 221211F (exp 6/10/07), 221212F (exp 6/12/07), 221213F (exp 6/12/07), 221214F (exp 6/13/07), 221215F (exp 6/13/07), 221216F (exp 6/14/07), 221217F (exp 6/14/07), 221218F (exp 6/15/07), 221219F (exp 6/15/07), 221220F (exp 6/16/07), 221221F (exp 6/16/07), 221222F (exp 6/17/07), 221223F (exp 6/17/07), 221224F (exp 6/19/07), 221225F (exp 6/19/07), 221226F (exp 6/20/07), 221227F (exp 6/20/07), 221228F (exp 6/21/07), 221229F (exp 6/21/07); All software versions
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 neck of the wash buffer cube can be extended higher than intended possibly causing the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. This may lead to incorrect assay results.
FDA Determined
Cause 2		 Other
Action A Product Corrective Action (PCA) letter was sent on July 28, 2006 to all Dxl customers to inform them that due to a recent change in packaging it is possible that the neck of the wash buffer cube can be extended higher than intended. This condition can cause the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. If they are running System software version 2.2.2 (distributed beginning March 2006) and greater it will detect the premature out-of-buffer state, thus preventing the potential for erroneous results. The letter also informed the customers that if they run system software version 2.2.1 or earlier with these wash buffer lot numbers, the premature out-of-buffer state will not be detected immediately, leading to the potential for erroneous results. They were informed that Installation of software version 2.2.2 or greater is mandatory. To ensure immediate upgrade to version 2.2.2, customers are to contact the Clinical Support Center or their local Beckman Coulter representative. After system software version 2.2.2 or greater is installed, the system will detect the out-of-buffer state, stop sample processing, and suppress results. One of the following Event Log messages will be posted: ''Air or excessive restriction has compromised wash buffer delivery'' or ''Air detected in the wash buffer supply line'' To prevent out-of-buffer events users are to complete the enclosed procedure: Calibrating the Wash Buffet Level Sensor. Completing the enclosed procedure before using any of the affected lots of Part Number 8547197 will eliminate unnecessary workflow interruptions. Customers are to share the information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. They are also instructed to complete and return the enclosed response form within 10 days so that the firm can be assured they were notified.
Quantity in Commerce 12,947 units
Distribution Worldwide distribution --- including USA and country of 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 = JJE and Original Applicant = BECKMAN COULTER, INC.
-
-