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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter UniCel Dxl 800 Access Immunoassay System

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 Class 2 Device Recall Beckman Coulter UniCel Dxl 800 Access Immunoassay Systemsee related information
Date Initiated by FirmFebruary 06, 2006
Date PostedMarch 03, 2006
Recall Status1 Terminated 3 on March 06, 2012
Recall NumberZ-0583-06
Recall Event ID 34581
510(K)NumberK023764 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
ProductUniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
Code Information Part Numbers: 386162 (software) 973100 (Instrument),  Software Versions 2.2.1 and earlier.  
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactNora Zerounian
714-961-3634
Manufacturer Reason
for Recall		The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)
FDA Determined
Cause 2		Software design
ActionA Product Corrective Action letter will be mailed the week of Feb 06 2006 to all UniCel 800 Dxl customers informing them of a rare condition on the UniCel Dxl 800 Access Immunoassay Systems. Under a specific set of circumstances, the UniCel Dxl 800 may aspirate a sample from an incorrect rack and generate a result, which is not flagged. (Letter is sent by US mail)
Quantity in Commerce280 total (263 in US & 17 in Canada)
DistributionNationwide and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJE
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