Cl Il BD FACSDiva Software v4.0.1 to 5.0.2

Company: BD Biosciences
Date of Enforcement Report 8/20/2008
Class:ll

PRODUCT
FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 Flexible data acquisition and analysis package specifically designed for digital-based flow cytometers; Recall # Z-1525-2008

REASON
When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.

RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA, by letter on April 20, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1074 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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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