Inc ClassII Abbott Laboratories

Company: Abbott Laboratories, Inc
Date of Enforcement Report: 11/28/01
Class: II

PRODUCT
The Abbott AxSYM System is a fully automated Immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA) Assay Technology, and Ion Capture (IC) Immunoassay Technologies. The AxSYM System performs random access, continuous access, and STAT processing of both large and small molecular weight analytes, Recall # Z-306-2 to Z-311-2.

REASON
The system may report sample results from the incorrect sample tube.

CODE
Software versions 3.00, 3.01, 3.03, 3.04a, 3.60, 4.00.

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter dated 9/26/01. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
17,508.

DISTRIBUTION
Nationwide and world wide.

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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