Z-1847-2014Class II

Abacus 3.1, Pharmacy Calculator

Name: Z-1847-2014 Abacus 3.1, Pharmacy Calculator
Creator: Baxter Corporation Englewood
Published: 2014-05-28
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2014-05-28 / Terminated / root cause: software

FDA source

Baxter Corporation Englewood began a recall of Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding on 2014-05-28. FDA classified it as Class II and gives the reason as "Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1847-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-28
Posted: 2014-06-22
Terminated: 2016-08-08
Recalling firm: Baxter Corporation Englewood
Product: Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.
Root cause tag: software
FDA root cause: Software design
Action: Baxter sent an Urgent Device Correction letter dated May 27, 2014 via certified mail to affected customers. The letter identified the affected product, problem and actios to be taken. Customers were instructed to: 1. Review and distribute this communication to pharmacy staff and compounding staff that use ABACUS software. This notice is intended only for customers that have upgraded to version 3.1 of the software. 2. Please acknowledge receipt of this notification by completing the enclosed customer reply form and return it to Baxter by either faxing it to 1-224-270-5457 or scanning and e-mailing it to [email protected]. 3. If you have distributed ABACUS to other facilities, please notify the end users in accordance with your customary procedures. For questions call Baxter Techenical Support line at 1-800-678-2292.
Quantity in commerce: 42
Distribution: US Nationwide Distribution and the state of VA.
Product codes and lots: Product Code: 8300-0167, 8300-0168, 8300-0169

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1847-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1847-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-21

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)