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U.S. Department of Health and Human Services

Class 2 Device Recall Vidiera NsP Nucleic Sample Preparation

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 Class 2 Recall
Vidiera NsP Nucleic Sample Preparation
see related information
Date Posted December 16, 2008
Recall Status1 Terminated on January 13, 2009
Recall Number Z-0454-2009
Recall Event ID 48660
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
Product Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41
Code Information Part Numbers: A22421, Version 1.0.41
Recalling Firm/
Manufacturer
Beckman Coulter Inc
200 S Kraemer Blvd
Brea, California 92822-6208
For Additional Information Contact Nora Zerounian
714-993-5321 Ext. 8383
Manufacturer Reason
for Recall
Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the "Run Results" report. The software error associated with the excluded sample appears as "Liquid was not successfully transferred to well#..........the sample will be excluded from further proce
FDA Determined
Cause 2
DESIGN: Software Design
Action The customer notifications were initiated by Beckman Coulter on September 11, 2007 when all affected accounts were contacted via telephone, followed by a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers of the issue and instructed them to: (1) Review the "run Summary" event log for your samples. (2) Review the attached instructions describing the steps for identifying the samples affected by this error. (3) Complete and return the enclosed response form within 10 days so that we may maintain our records. The letter informed the customers that Beckman Coulter would provide a software update within 60 days. The letter also asked their customers to share the PCA with their staff and provide a copy of the PCA to any customers that they may have forwarded the affected products to. For questions regarding the PCA, please contact firm at 714-961-3634.
Quantity in Commerce 6
Distribution Nationwide distribution including states of PA, MI, UT, WA, IL, and CA.
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.
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