FDA: Class I recall of Baxter’s Abacus software app

Editor's Note

The Food and Drug Administration (FDA) on July 25 identified the recall by Baxter Healthcare Corporation of its Abacus Order Entry and Calculation Software application as Class I, the most serious.

The Abacus software app can translate a physician’s order into a compounded solution.

The recall was initiated because of the risk that final printed labels for the compounded solution may contain incorrect information. The issue may occur when a user unintentionally or incorrectly modifies a label template.

There have been five complaints, no injuries, and no deaths associated with this issue.

Distribution dates were May 20, 2013 to September 20, 2019.

Baxter is performing a software upgrade to remove the ability of all Abacus users to change label templates.