CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report

Abacus 3.1, Pharmacy Calculator recalled by Baxter Corporation Englewood

Baxter Corporation Englewood is recalling Abacus 3.1, Pharmacy Calculator, distributed nationwide in the US. The recall was initiated on 28 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 8300-0167, 8300-0168, 8300-0169

Quantity recalled42

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1847-2014
FDA event ID: 68256
Recalling firm: Baxter Corporation Englewood, Englewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2014
FDA classified: 21 Jun 2014
Reported: 2 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

28 May 2014	Recall initiated by company
21 Jun 2014	Classified by FDA	+24 days
2 Jul 2014	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide Distribution and the state of VA.

Nationwide Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide Distribution and the state of VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Baxter Corporation Englewood

All 9

Reported	Class	Recall	Company	Reason	Where
12 Oct 2016Device	CLASS I	0.2 Micron Filter recalled by Baxter Corporation Englewood	Baxter Corporation Englewood	Particulate Matter	Nationwide
10 Feb 2016Device	CLASS II	Baxter, Rapidfill Syringe Strip For use recalled	Baxter Corporation Englewood	Packaging Defects	Nationwide
27 May 2015Device	CLASS II	Abacus SE (Single-Workstation Edition) and Abacus ME recalled	Baxter Corporation Englewood	Device Malfunction	Nationwide
11 Mar 2015Device	CLASS II	Baxter, Self-Righting Syringe Tip Caps recalled	Baxter Corporation Englewood	Other	Nationwide
31 Dec 2014Device	CLASS II	Self-Righting Luer Lock Tip Cap, Green recalled	Baxter Corporation Englewood	Foreign Material	4 states

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