Becton Dickinson Microbiology Systems Class II

Company: Becton Dickinson Microbiology Systems
Date of Enforcement Report: 9/25/02
Class: II

PRODUCT
Becton Dickinson’s EpiCenter Data Management System software.
Recall # Z-1338-2.

REASON
IVD software defect may cause incorrect patient results to be reported.

CODE
EpiCenter Software, version 3.20B, Catalog #441007.

RECALLING FIRM/MANUFACTURER
Becton Dickinson Microbiology Systems, Sparks, MD, by letter on August 1, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
336 units.

DISTRIBUTION
Nationwide and Internationally.

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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