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 | K023049 K060256 K922823 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = JJE 510(K)s with Product Code = JJE
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