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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix…"
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…
- 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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