Company: Beckman Coulter IncDate of Enforcement Report 12/24/2008 Class:ll PRODUCT Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41, Recall # Z-0454-2009 REASON 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...Read More

http://www.fda.gov/cdrh/manual/pmamanul.pdfRead More

http://www.fda.gov/cdrh/devadvice/314.htmlRead More

This topic provides educational checklists related to several standards and regulations. SoftwareCPR checklists are available to paid subscribers of www.softwarecpr.com by using their login. These are only intended for use by those experienced in the related regulations and standards and are not intended to be used blindly as there may be significant interpretational ambiguities and...Read More