FDA Provides Update on Baxter Healthcare’s Recall of Its Abacus Software

The FDA has issued an update on Baxter Healthcare’s June 22 recall of its Abacus order entry and calculation software, deeming it a Class 1 recall because of the risk of serious injury or death.

The order entry software performs calculations for compounding liquid doses of medications. Baxter issued the recall because of a risk that final printed bag labels for the compounded mixtures may contain incorrect information if users unintentionally or incorrectly modify a label template.

Incorrect values or patient names could cause serious harm, especially if the wrong amounts or wrong medications are administered to high-risk patients, the FDA said.

The affected software was distributed from May 20, 2013 to Sept. 20, 2019. There have been five complaints, but no injuries or deaths associated with the software issue so far, the agency said.