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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 Recall
Access Power Supply Assembly Sled
see related information
Date Posted August 20, 2008
Recall Status1 Open
Recall Number Z-1183-2008
Recall Event ID 46316
Premarket Notification
510(K) Numbers
K023049  K060256  K922823 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - 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, California 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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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