Nov

2003

Inc. Class II Abbott Laboratories

Company: Abbott Laboratories, Inc
Date of Enforcement Report: 11/19/03
Class: II

PRODUCT
AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit. Recall # Z-0091-04.

REASON
Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.

CODE
Version 1.02ER000 and Version 1.02ER000 Upgrade Kit.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on September 30, 2003. Firm initiated the recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
133.

DISTRIBUTION
Nationwide and Internationally.

About the author

Amy Sellers

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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Inc. Class II Abbott Laboratories

Amy Sellers

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