Baxter ABACUS TPN Calculation Software Recalled for Data Corruption Risk
Baxter is voluntarily correcting ABACUS TPN software versions 2.0-3.0 because data corruption could cause patients to receive another patient's TPN order.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical software) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed incidents.
Plain-English summary
Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total Parenteral Nutrition (TPN) Calculation Software, versions 2.0 through 3.0. The affected software includes the ABACUS CE (Calculator Edition), ABACUS SE (Single-Workstation Edition), and ABACUS ME (Multi-Workstation Edition). This software is a Windows-based application used for comprehensive TPN order calculations and label printing.
The recall is due to the possibility that a patient could receive another patient's TPN order as a result of data corruption. The source text does not specify the number of affected units, the specific distribution locations, or whether any adverse events have been reported.
Healthcare facilities using this software should contact Baxter Healthcare Corporation for instructions on how to correct the software. Consumers are not directly affected as this is a professional medical software application.
The recalled product
- Product
- ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations a
- Manufacturer
- Baxter Corporation Englewood
- Category
- Medical Device — Software
- Affected units
- 2,211
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product Code: 8300-0045
- 8300-0046
- 8300-0047
- 8300-0045
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Baxter Corporation Englewood
See all →- HighBaxter Recalls 0.2 Micron Filters Due to Missing Membrane
FDA (Devices) · 2016-10-12
- ModerateBaxter RAPIDFILL Syringe Strips Recalled for Shelf Life Packaging Claim
FDA (Devices) · 2016-02-10
- HighBaxter ABACUS Software Recalled for Potential TPN Formula Loading Errors
FDA (Devices) · 2015-05-27
- ModerateBaxter Recalls Syringe Tip Caps for Missing Latex Symbol
FDA (Devices) · 2015-03-11
- ModerateBaxter Recalls Self-Righting Luer Tip Caps Due to Validation Timing
FDA (Devices) · 2014-12-31
Same hazard · data corruption
See all →- HighSynchroMed II Infusion Pump Recalled Due to Memory Data Corruption
FDA (Devices) · 2024-10-30
- HighPhilips Recalls IntelliSpace PACS 4.4 Due to Potential Image Corruption
FDA (Devices) · 2020-06-17
- HighElekta Recalls Leksell GammaPlan Software Due to Memory Corruption
FDA (Devices) · 2015-06-17
- ModerateSiemens LANTIS System Recall for Unvalidated Operating System Risks
FDA (Devices) · 2014-07-02