The Recall Desk
SevereFDA (Devices)·Z-1376-2022·Announced 2022-08-03

ABACUS TPN Calculation Software recalled for medication error risk

Baxter Healthcare's ABACUS TPN calculation software poses a potential risk of medication error. The FDA issued a Class I recall; healthcare providers should contact the manufacturer for guidance.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. The recall addresses a potential risk of medication error in a drug delivery and calculation system, which could cause serious patient harm.

Plain-English summary

ABACUS TPN (Total Parenteral Nutrition) Calculation software is manufactured by Baxter Healthcare Corporation and is used with ExactaMix automated compounding devices to calculate formulations for parenteral nutrition preparations. Multiple software versions are affected, including versions 3.1, 3.2, and 3.3.

The FDA has classified this as a Class I recall due to a potential risk of medication error when using the software. Medication errors in parenteral nutrition calculations could result in serious health consequences for patients.

This recall affects 9 units distributed internationally, including the United States (including Puerto Rico), Canada, Argentina, Chile, Colombia, Bermuda, Dominican Republic, Panama, Vietnam, Hong Kong, Singapore, and EMEA regions.

Healthcare providers using ABACUS TPN software should contact Baxter Healthcare Corporation or consult FDA guidance regarding this recall. Healthcare facilities should review their use of affected software versions and follow manufacturer guidance for any corrections or updates.

The recalled product

Product
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), 8300-3
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Medication Calculation Software
Hazard
  • medication-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Product Code 8300-3391
  • UDI (01)05413765577345(10)3.3.2.1
  • Release date 20-Sep-2019
  • Product Code 8300-3392
  • UDI (01)05413765577352(10)3.3.2.1
  • Product Code 8300-3393
  • UDI (01)05413765577369(10)3.3.2.1
  • Product Codes: 8300-0167
  • V3.1 CE
  • Release date 20-May-2013
  • 8300-0168
  • V3.1 SE
  • 8300-0169
  • V3.1 ME
  • 8300-0191
  • V3.2 CE
  • Release date 17-Dec-2015
  • 8300-0192
  • V3.2 SE
  • 8300-0193

Distribution

Distribution scope not specified by the agency.

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