The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Name: Abacus Order Entry and Calculation Software
- Product Codes: See medical device database entry
- Devices Recalled in the U.S.: 9 (3 versions of software with 3 configurations)
- Affected Customers: 1,114
- Dates distributed: May 20, 2013, to September 20, 2019
- Date Initiated by Firm: June 22, 2022
Device Use
Abacus is a software application that performs calculations for compounding liquid doses of medications. When connected to a compounder that mixes these doses according to the calculation, the Abacus software can translate a physician’s order into a compounded solution ready to be given to a patient.
Reason for Recall
Baxter Healthcare Corporation is recalling the Abacus software application due to a risk that final printed bag labels for compounded mixtures may contain incorrect information. The issue may occur if a user unintentionally or incorrectly modifies a label template that is used to provide clinical care.
Incorrect values or patient names on final printed bag labels for compounded medications may cause serious harm, especially if the wrong amounts or wrong medications are administered to high-risk patients.
There have been 5 complaints, no injuries, and no deaths associated with this software issue.
Who May Be Affected
- Health care administrators and staff with administrative permission to access and modify label templates using the Abacus software.
- Health care providers who order and administer medications that are calculated and prepared with the assistance of Abacus software.
- People who receive medications prepared with the assistance of the Abacus software.
What to Do
On June 22, 2022, Baxter Healthcare Corporation issued an Urgent Medical Device Correction letter to customers informing them that the company will perform a software upgrade to remove the ability of all Abacus users to change label templates.
In the meantime, the company recommended that users:
- Follow instructions in the Abacus User Guide and Abacus Configuration Guide when creating an order.
- Have a pharmacist review all order outputs, including the printed bag label.
- Ensure facility processes include pharmacy checks during the compounding process as well as a nursing check.
- Do not make updates to bag label templates.
- Contact Baxter Technical Service if changes to label templates are needed.
- Forward a copy of this information to any facility or department that uses this product.
- Users who received the letter directly from Baxter should acknowledge receipt of the correction letter through the Baxter customer portal: https://BaxterFieldActionCustomerPortal.onprocess.com/.
Baxter will provide more information to customers about the software upgrade when it becomes available.
Contact Information
Customers with questions or concerns about this recall should contact Baxter Technical Service at 800-678-2292 between 8:00 am and 7:00 pm Eastern time, Monday through Friday.
Additional Resources:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
