FDA Medical Device Recalls (openFDA)
Baxter Corporation Englewood: Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
- Recall number
- Z-1847-2014
- Recalling firm
- Baxter Corporation Englewood
- Product
- Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
- Status
- Terminated
- Initiated
- 2014-05-28
- Posted
- 2014-06-22
- Terminated
- 2016-08-08
- Reason
- 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
- 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 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.
- Quantity
- 42
- Distribution
- US Nationwide Distribution and the state of VA.
- Lot, serial or model codes
- Product Code: 8300-0167, 8300-0168, 8300-0169
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEP
- Firm FEI
- 1419106
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28