The Recall Desk
ModerateFDA (Devices)·Z-1847-2014·Announced 2014-07-02

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.

What this means for you

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.
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Baxter Corporation Englewood

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