Baxter ABACUS Software Recalled for Potential TPN Formula Loading Errors
Baxter is recalling ABACUS SE and ME software because it may load incorrect total parenteral nutrition formulas when duplicate order numbers are used.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 used for TPN calculations where an error could lead to the administration of an incorrect formula. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are mentioned in the source text.
Plain-English summary
Baxter Corporation is conducting a field action for the ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) software. The ABACUS Software is a Windows-based order entry application used for comprehensive total parenteral nutrition (TPN) calculations and label printing.
The recall is due to the possibility that the compounder will load the incorrect formula upon scanning the bag label. This error can occur when two or more different formula files have been created with the same order number.
The affected units were distributed worldwide and across the US. The source text does not specify the number of affected units, specific dates, or reported injuries. Users of the software should contact Baxter Corporation for further instructions on the field action.
The recalled product
- Product
- ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
- Manufacturer
- Baxter Corporation Englewood
- Category
- Medical Device — Software
- Affected units
- 882
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 (6)
- Product Codes: 8300-0168
- 8300-0169
- 8300-0157
- 8300-0158
- 8300-0046
- 8300-0047
Distribution
Distributed nationwide across the United States.
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