Device Recall Vidiera NsP Nucleic Sample Preparation 의 리콜

Recall

48660

Class 2

Z-0454-2009

2007-08-30

2008-12-16

Terminated

United States

2009-01-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71828

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.

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.