Inc Class II Abbott Laboratories

Company: Abbott Laboratories, Inc

Date of Enforcement Report: 3/24/02
Class: II

PRODUCT
AEROSET System Software v1.00ER005.2 and v1.0ER005
Catalog Numbers: 2-8996-02 and 2-89996-01. Recall # Z-0594-2/0595-2.

REASON
System may incorrectly associate sample ID & test requests undercertain conditions of non-bar coded or unreadable bar coded samples.

CODE
All Codes are affected by this field correction.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter dated December 7, 2001.
Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
535.

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.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.