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.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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

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