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U.S. Department of Health and Human Services

Class 2 Device Recall Abacus 3.1

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 Class 2 Device Recall Abacus 3.1see related information
Date Initiated by FirmMay 28, 2014
Date PostedJune 22, 2014
Recall Status1 Terminated 3 on August 08, 2016
Recall NumberZ-1847-2014
Recall Event ID 68256
Product Classification System/device, pharmacy compounding - Product Code NEP
ProductAbacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
Code Information Product Code: 8300-0167, 8300-0168, 8300-0169
Recalling Firm/
Manufacturer		 Baxter Corporation Englewood
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.
FDA Determined
Cause 2		Software design
ActionBaxter sent an Urgent Device Correction letter dated May 27, 2014 via certified mail to affected customers. The letter identified the affected product, problem and actios to be taken. Customers were instructed to: 1. Review and distribute this communication to pharmacy staff and compounding staff that use ABACUS software. This notice is intended only for customers that have upgraded to version 3.1 of the software. 2. Please acknowledge receipt of this notification by completing the enclosed customer reply form and return it to Baxter by either faxing it to 1-224-270-5457 or scanning and e-mailing it to fca@baxter.com. 3. If you have distributed ABACUS to other facilities, please notify the end users in accordance with your customary procedures. For questions call Baxter Techenical Support line at 1-800-678-2292.
Quantity in Commerce42
DistributionUS Nationwide Distribution and the state of VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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