ABACUS TPN Calculation Software — Class I medical device recall Z-1566-2014
Terminated recall by Baxter Corporation Englewood, reported 2014-05-21, distributed nationwide. 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creatio
| Recall number | Z-1566-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Corporation Englewood, Englewood, CO, United States |
| Recall initiated | 2014-04-02 |
| Classified | 2014-05-12 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2016-01-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BG, BH, CA, CH, CO, DE, DO, EE, FR, GB, HK, HU, IE, IL, JO, KW, LV, MA, OM, PA, QA, SA, SI, SK, TW, ZA |
| Quantity | 2,034 |
| Reason classes | sterility, software |
Product
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, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1566-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.