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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 Sledsee related information
Date Initiated by FirmOctober 17, 2007
Date PostedAugust 20, 2008
Recall Status1 Terminated 3 on April 27, 2012
Recall NumberZ-1183-2008
Recall Event ID 46316
510(K)NumberK023049 K060256 K922823 
Product Classification power supply for in vitro diagnostic - Product Code JJE
ProductAccess 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 ContactNora 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
ActionBeckman 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 Commerce3055 instruments in the US; 192 instruments in Canada
DistributionNationwide Distribution 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
510(K)s with Product Code = JJE
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