Baxter Abacus 3.1 Pharmacy Calculator Software Field Correction
Baxter is correcting a software error in Abacus 3.1 that may display protein levels 1,000 times lower than actual when using Clinimix 4.25110.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a software calculation error that could lead to incorrect nutritional labeling, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Baxter Corporation is initiating a field correction for the Abacus 3.1 Pharmacy Calculator software. The issue occurs when the software is upgraded to version 3.1 and Clinimix 4.25110 is used in an order. In these specific instances, the Nutritional Summary and any labels containing energy information may display protein levels that are 1,000 times less than the amount actually present in the solution.
The recall affects 42 units of the software distributed nationwide in the US and in the state of Virginia. The product codes associated with this correction are 8300-0167, 8300-0168, and 8300-0169.
This is a field correction to address a software calculation error. Users of the Abacus 3.1 Pharmacy Calculator should verify their software version and apply the necessary correction to ensure accurate protein calculations for automated compounding.
The recalled product
- Product
- Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
- Manufacturer
- Baxter Corporation Englewood
- Category
- Medical Device — Software
- Affected units
- 42
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 (3)
- Product Code: 8300-0167
- 8300-0168
- 8300-0169
Distribution
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