Baxter Healthcare Corporation Recalls Abacus Software for Risk of Medication Label Errors

July 26, 2022

On July 25, 2022, the U.S. Food and Drug Administration (FDA) reported ( Baxter Healthcare Corporation’s recall of the Abacus order entry and calculation software because of a printing error that could cause final bag labels for compounded mixtures to be incorrect. FDA identified it as a class I recall, the most serious type of recall, where use of the software may cause serious injuries or death.

Baxter Healthcare Corporation Recalls Abacus Software for Risk of Medication Label Errors

Baxter Healthcare Corporation received five reports from customers experiencing the software issue, none of which were associated with injuries or deaths. The recall affects nine devices (three versions of the software with three configurations) and 1,114 customers. The software was distributed from May 20, 2013– September 20, 2019. For a list of recalled product codes, see FDA’s medical device database (

The issue can occur if a user unintentionally or incorrectly modifies a label template. If final printed bag labels for compounded medicine are incorrect, administering the wrong dose or wrong type of medication can cause serious harm, especially for high-risk patients.

FDA reported that Baxter Healthcare Corporation notified customers by letter in June 2022 that it will perform a software upgrade on Abacus to remove the ability to change label templates. Customers were instructed to acknowledge receiving the letter on the Baxter Healthcare Corporation customer portal (

Until the software is upgraded, Baxter Healthcare Corporation recommended:

Customers with questions about the recall can contact Baxter Technical Service at 800-678-2292 Monday–Friday, from 8 am–7 pm EST. 

Healthcare professionals and consumers should report any adverse reactions or quality problems ( they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.

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