Oct

1998

589 units Abbott AxSYM System Class II 3

Software for the Abbott AxSYM System, a fully automated immunoanalyzer. Recall #Z-331-9.

REASON

Extra assay results from a previous run can appear with new sample results, as well as error messages,
due to software defect in the internal result database management.

CODE

All software versions below 3.03.

MANUFACTURER

Abbott Laboratories, Irving, Texas.

RECALLED BY

Abbott Laboratories, Diagnostics Division, Abbott Park, Illinois, by sending upgrade kits in November
1997, and by letter on October 26, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

3,589 instruments with software versions below 3.03 were distributed.

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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589 units Abbott AxSYM System Class II 3

Amy Sellers

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