FDA Device recall Z-1566-2014
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition),…
- FDA Device
- Class I
- terminated
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class I recall of ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition),… by Baxter Englewood, citing 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 ster….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1566-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-04-02 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Englewood |
| Distribution | US |
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
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
Identifiers
| code_info | Product Code 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1566-2014%22
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