Baxter ABACUS TPN Calculation Software Recalled for Calculation Errors
Baxter Corporation is recalling ABACUS TPN Calculation Software because it may calculate incorrect electrolyte quantities and display inaccurate data.
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 medical device with calculation errors that could lead to incorrect patient dosing (risk of harm), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Corporation is recalling ABACUS TPN Calculation Software, a Windows-based application used for Total Parenteral Nutrition (TPN) order calculations and label printing. The recall involves 2,034 units of the software, including various versions such as ABACUS CE, SE, ME, and 3.0/3.1 editions. The product was distributed worldwide, including the United States, Canada, and numerous countries in Europe, the Middle East, and Asia.
The recall was initiated because the software contains calculation and display errors. Specifically, ABACUS v3.1 may calculate electrolyte quantities that are double the expected values and may automatically add excessive sterile water to formulas, resulting in over-dilution. Additionally, all software versions display calcium phosphate curve points for Premasol incorrectly. These errors could lead to inaccurate TPN orders.
Healthcare facilities and users who have purchased or are using ABACUS TPN Calculation Software should stop using the affected versions and contact Baxter Corporation for instructions on how to proceed. The recall covers specific product codes including 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, and 8300-0169.
The recalled product
- Product
- ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS
- Manufacturer
- Baxter Corporation Englewood
- Category
- Medical Device — Software
- Affected units
- 2,034
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 (10)
- Product Code 8300-0045
- 8300-0046
- 8300-0047
- 8300-0156
- 8300-0157
- 8300-0158
- 8300-0166
- 8300-0167
- 8300-0168
- 8300-0169
Distribution
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