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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel Dxl Access Immunoassay Systems Reaction Vessels

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  Class 2 Device Recall UniCel Dxl Access Immunoassay Systems Reaction Vessels see related information
Date Initiated by Firm July 19, 2007
Date Posted March 19, 2008
Recall Status1 Terminated 3 on May 04, 2012
Recall Number Z-1108-2008
Recall Event ID 46362
510(K)Number K023764  
Product Classification Chemistry Analyzer - Product Code MMI
Product UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822
Code Information Part Number: 386167; Lot Code: 1201291 & 1201431
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nora Zerounian
714-961-3634 Ext. 8383
Manufacturer Reason
for Recall		 Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result.
FDA Determined
Cause 2		 Process design
Action A Product Corrective Action (PCA) letter was mailed on July 19, 2007, to the Customers that received UniCel Dxl Access lmmunoassay System Reaction Vessels lot 1201291 and 1201431. The customers were informed that a small percentage of the reaction vessels (Lot #s: 1201291and 1201431 ) have been found to be defective and there is a potential for an increase in signal leading to an erroneous result. The customers were instructed to discontinue use and discard these lots. A response form was included.
Quantity in Commerce 264 units in the US; 9 units in Canada
Distribution Nationwide & 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 = MMI and Original Applicant = BECKMAN COULTER, INC.
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