CLASS II Device recall · Reported 27 May 2015 · FDA Enforcement Report
Abacus SE (Single-Workstation Edition) and Abacus ME recalled
Baxter Corporation Englewood is recalling Abacus SE (Single-Workstation Edition) and Abacus ME (Multi-Workstation Edition), distributed nationwide in the US. The recall was initiated on 8 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1628-2015
- FDA event ID
- 70946
- Recalling firm
- Baxter Corporation Englewood, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2015
- FDA classified
- 18 May 2015
- Reported
- 27 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 8 Apr 2015 | Recall initiated by company | |
| 18 May 2015 | Classified by FDA | +40 days |
| 27 May 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Why was it recalled?
Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.
Which lots are affected?
Product Codes: 8300-0168 ,8300-0169 ,8300-0157 ,8300-0158 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047,
Where was it sold?
Worldwide Distribution - US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Baxter Corporation Englewood
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | 0.2 Micron Filter recalled by Baxter Corporation Englewood | Baxter Corporation Englewood | Particulate Matter | Nationwide |
| Device | CLASS II | Baxter, Rapidfill Syringe Strip For use recalled | Baxter Corporation Englewood | Packaging Defects | Nationwide |
| Device | CLASS II | Baxter, Self-Righting Syringe Tip Caps recalled | Baxter Corporation Englewood | Other | Nationwide |
| Device | CLASS II | Self-Righting Luer Lock Tip Cap, Green recalled | Baxter Corporation Englewood | Foreign Material | 4 states |
| Device | CLASS II | Abacus 3.1, Pharmacy Calculator recalled by Baxter Corporation Englewood | Baxter Corporation Englewood | Device Malfunction | Nationwide |
Other Medical Software recalls
All 935| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Metatarsophalangeal (MTP) Implant is a sterile recalled by restor3d | restor3d | Sterility | Nationwide |
| Device | CLASS II | Ion Torrent Genexus Dx recalled by Life Technologies Holdings Pte | Life Technologies Holdings Pte | Device Malfunction | Nationwide |
| Device | CLASS II | Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |