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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:124436

ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include: non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes

Official recall number

Z-0539-2014

Evidence summary

Product code
LNX
Recall status
Terminated
Event initiated
December 03, 2013
Root cause
Unknown/Undetermined by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0539-2014