Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.

FDA device recall Z-1847-2014 · posted 2014-06-22 · Terminated

Recall details

Recalling firm

Baxter Corporation Englewood

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.

Action taken

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 fca@baxter.com. 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.

Root cause

Software design

Status

Terminated

Product code

NEP

Quantity affected

42

Distribution

US Nationwide Distribution and the state of VA.

Date initiated

2014-05-28

Date posted

2014-06-22

Date terminated

2016-08-08

Location

Englewood, CO