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.