May

2003

Inc Class II Abbott Laboratories

Company: Abbott Laboratories, Inc
Date of Enforcement Report: 5/21/03
Class: II

PRODUCT
AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01. Recall #Z-0788-03.

REASON
Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.

CODE
All lots.

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 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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