ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393 (Abacus V3.3 ME). Commonly used with ExactaMix automated compounding devices (ExactaMix 1200 and ExactaMix 2400).
FDA Recall Z-1376-2022 · Posted 2022-07-22
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Reason for Recall
Firm Action
Root Cause
Software design
Distribution Pattern
United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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