FDAClass IIJuly 2, 2014

Abacus 3.1 recall: Software Issue

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

Why was Abacus 3.1 recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code: 8300-0167, 8300-0168, 8300-0169

Product
Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
Recalling firm
Baxter Corporation Englewood
Quantity
42
Distribution
US Nationwide Distribution and the state of VA.
Recall date
July 2, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls