—#210127

Product

BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: UDI-DI: 00382904441500 Software versions: 4.20, 4.30, 5.10, 5.20 and 5.30

Why it was recalled

Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

BD issued Urgent Medical Device Correction letter on 12Sep2024. Letter states reason for recall, health risk and action to take: 1.Immediately identify if you have the affected software version noted in the affected product tableabove. Reference Attachment 2 for software version verification instructions. 2.Determine if the feature is active in your system by reviewing the system settings. Refer toAttachment 3 for System settings breakpoint feature instructions. 3.If the inline breakpoint feature is enabled, please disable the feature and keep disabled untilupgraded to Synapsys" software versions 5.31 or later. Refer to Attachment 3 for Systemsettings breakpoint feature instructions. 4.Ensure the contents of this notification are read and understood. 5.Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 6.Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the affected software versions, so that BD may acknowledge your receipt of this notification per FDA requirements. Actions taken by BD 1.BD has identified the root cause and is taking action to prevent recurrence of this product issue. 2.BD has resolved the issue in software versions 5.31 and later. If you require further assistance, please contact: BD Contact US Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Nationwide Foreign: Australia, New Zealand, Singapore, Hong Kong, Taiwan, Japan, Austria, Belgium, Denmark, France, Germany, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, Russia, Saudi Arabia, South Africa, Canada, Mexico, China

Timeline

Recall initiated: 2024-09-12
Posted by FDA: 2024-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210127. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.