30
Apr
2003

Inc Class III Abbott Laboratories

0

Company: Abbott Laboratories, Inc
Date of Enforcement Report: 4/30/03
Class: III

PRODUCT
Aeroset Software versions 1.00ER005, catalog number 2-89996-01; and software version 1,00ER005.2, catalog number 2-89996-02. Recall # Z-0725-03.

REASON
Under certain operating conditions, smart wash feature disables with multiple samples.

CODE
No codes.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on February 24, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
645 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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