Food, drugs, devices › Baxter Corporation Englewood
Device recall: ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Wo
Baxter Corporation Englewood (Englewood, CO) initiated this device recall on 2 Apr 2014; FDA lists 1 product record under event 67884, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 5% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 20 Jan 2016. Initiation: voluntary: firm initiated. Baxter Corporation Englewood has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Baxter Corporation Englewood, Englewood, CO.
Reason for recall
"1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software v"
Distribution
"Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1566-2014 | ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE,… | 2034 | Class I | Terminated | 21 May 2014 |
Context
Other enforcement events for Baxter Corporation Englewood
All 9 events for Baxter Corporation Englewood
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software v"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Jan 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.