6.1 , Cl Il BD Biosciences-FACSDiva Software 6.0

Company: BD Biosciences
Date of Enforcement Report 8/13/2008
Class:ll

PRODUCT
BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System Model/Catalog number 642685 Software is used to simplify acquisition of flow cytometry data, Recall # Z-1530-2008

REASON
Values might not update in statistics views after certain functions are performed in a worksheet.

RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA, by letter on December 21, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
74 units

DISTRIBUTION
Nationwide

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

Upcoming Training

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.