The FDA issued a notice today announcing that the recall of the Baxter Abacus software is Class I, the most serious kind.

Baxter designed its Abacus order entry and calculation software to perform calculations for compounding liquid doses of medications. When connected to a compounded that mixes doses according to the calculation, the software can translate a physician’s order into a compounded solution ready to be given to a patient.

The company recalled the software application due to a risk that final printed bag labels for compounded mixtures may contain incorrect information, with the issue potentially occurring if a user unintentionally or incorrectly modifies a label template used to provide clinical care. Incorrect values or patient names on these labels may cause serious harm, especially if the wrong amounts or wrong medications are administered to high-risk patients. There have been five complaints, zero injuries and zero deaths related to the issue.

Baxter recalled nine devices in the U.S. — three versions of software with three configurations. There are 1,114 affected customers, according to the FDA notice, with the affected products distributed between May 20, 2013, and Sept. 20, 2019. Baxter initiated the recall on June 22, 2022 via an urgent medical device correction letter.

The correction letter informed customers that the company will perform a software upgrade to remove the ability of all Abacus users to change label templates. In the meantime, customers have been instructed to follow directions in the platform’s user guide when creating an order.

Users should also have a pharmacist review all order outputs (including the printed bag label) and ensure facility processes include pharmacy checks during the compounding process as well as a nursing check. Users should not make updates to bag label templates and they should contact Baxter’s technical service if changes to label templates are needed.

Baxter said it will provide more information to customers about the software upgrade when it becomes available.