Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 21, 2014
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
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 ste…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Corporation Englewood recalled ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition),… - a critical-severity action.
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition),… was recalled by Baxter Corporation Englewood in May 21, 2014. Reason: 1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creati…. Check the official notice for the remedy. Verify recall #Z-1566-2014 with the FDA Devices before acting.
The recall
Baxter Corporation Englewood issued this critical-severity FDA Devices recall-1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creati….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- May 21, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1566-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1566-2014) was formally reported on May 21, 2014, with the manufacturer initiating the action on April 2, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Baxter Corporation Englewood is listed as the recalling firm, operating out of Englewood, CO. Federal records list the affected scope as 2034.
The documented reason for this recall is: 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 vol… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel, Jordan, Kuwait, Latvia,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2034
Related Recalls
6
3 from same agency
Product description
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 for recall
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1566-2014 |
| Date reported | May 21, 2014 |
| Date initiated | April 2, 2014 |
| Recalling firm | Baxter Corporation Englewood |
| Firm location | Englewood, CO |
| Affected scope | 2034 |
| Distribution | Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel, Jordan, Kuwait, Latvia, Morocco, Oman, Qata… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1566-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Corporation Englewood. Units affected: 2034.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 21, 2014. Severity: Critical. Recall number: Z-1566-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel, Jordan, Kuwait, Latvia, Morocco, Oman, Qatar, Saudi Arabia, Slovenia, Slovakia, South Africa, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, and Taiwan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1566-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 21, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.