FDA-Device2014-07-02Class II

Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.

Baxter Corporation Englewood
Hazard

Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.

Sold states
US Nationwide Distribution and the state of VA.
Affected count
42
Manufactured in
14445 Grasslands Dr, N/A, Englewood, CO, United States
Products
Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1847-2014

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