18
Aug
2008

6.1 , Cl Il BD Biosciences-FACSDiva Software 6.0

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.

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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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