Z-1436-2012

Abacus TPN Calculating Software

Name: Z-1436-2012 Abacus TPN Calculating Software
Creator: Baxa Corporation
Published: 2009-01-19
License: https://open.fda.gov/license/

Baxter Corporation Englewood / initiated 2009-01-19 / Terminated / root cause: labeling and UDI

FDA source

Baxa Corporation began a recall of Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation on 2009-01-19. The reason FDA records is "Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1436-2012
Status: Terminated
Initiated: 2009-01-19
Posted: 2012-05-25
Terminated: 2012-09-12
Recalling firm: Baxter Corporation Englewood
Product: Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.
Product code: LNX
Reason for recall: Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Baxa Corporation sent a "Safety Alert" letter dated January 19, 2009 via FedEx to all affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to ensure that users create either a salt-based template OR an ion-based template for ordering, and that both methods of ordering are not used in one template. Customers were provided a list of safe practices to follow on the enclosed ISMP Safety Alert. Customers were advised upon receipt of the Safety Alert that Baxa Technical Support will review and address any issues with the customer on their configuration setup for calcium and magnesium. For questions contact Baxa Technical Support at 1-800-678-2292.
Quantity in commerce: 667 units
Distribution: Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia.
Product codes and lots: Catalogue Numbers: 8300-0045: Abacus Calculator Only (Abacus CE) 8300-0046: Abacus Single Work Station (Abacus SE) 8300-0047: Abacus Multi-Work Station (Abacus ME)

Product code LNX

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)