27
Mar
2002

Inc Class II Abbott Laboratories

0

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.

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