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U.S. Department of Health and Human Services

Class 2 Device Recall Access Power Supply Assembly Sled

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  Class 2 Device Recall Access Power Supply Assembly Sled see related information
Date Initiated by Firm October 17, 2007
Date Posted August 20, 2008
Recall Status1 Terminated 3 on April 27, 2012
Recall Number Z-1183-2008
Recall Event ID 46316
510(K)Number K922823  K023049  K060256  
Product Classification power supply for in vitro diagnostic - Product Code JJE
Product Access Power Supply Assembly Sled
Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use.
Code Information Part Number A48196/6845C; Instrument part numbers 81600 and  81600N
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		 Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering.
FDA Determined
Cause 2		 Process control
Action Beckman Coulter mailed a Product Corrective Action (PCA) letter on October 17, 2007 to all Access and Access 2 lmmunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System customers. The customers were informed that during manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering. The letter referenced a proactive initiative to inspect the power supply sled assemblies on all instruments referenced. A response form was included.
Quantity in Commerce 3055 instruments in the US; 192 instruments in Canada
Distribution Nationwide Distribution and 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.
510(K)s with Product Code = JJE and Original Applicant = BIO-RAD LABORATORIES, INC.
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