Class 2 Device Recall BD Synapsys Microbiology Informatics Solution

• Date Initiated by Firm: March 09, 2022
• Create Date: April 29, 2022
• Recall Status: Terminated on January 19, 2024
• Recall Number: Z-1018-2022
• Recall Event ID: 89896
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
• Code Information: All systems running BD Synapsys version 4.10; UDI: 00382904441500; Serial Numbers: SL00530 SL00515 SL00527 SL00502 SL00540 SL00564 SL00549 SL00509 SL00003 SL00004 SL00010 SL00001 SL00005 SL00002 SL000015 SL01010 SL01022
• FEI Number: 1119779
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• Manufacturer Reason for Recall: When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
• FDA Determined Cause: Under Investigation by firm
• Action: A MEDICAL DEVICE CORRECTION notification letter dated 3/9/22 was distributed to customers. PLEASE TAKE THE FOLLOWING ACTIONS: 1. Ensure the contents of this notification are read and understood by those within your organization. 2. BD will be contacting you within one week to request remote access to your database to confirm your configuration and evaluate potential impact. If BD determines that your facility has an affected configuration, BD will work with your facility to resolve the issue. In the interim, you many continue use of the product until BD contacts your facility. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form so that BD may acknowledge your receipt of this notification per FDA requirements. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 Actions Taken by BD: 1. BD will review configuration and evaluate potential impact for BD Kiestra customers. 2. Corrective actions have been initiated to prevent recurrence of the identified root cause. If you require further assistance, please contact:
• Quantity in Commerce: 15 systems
• Distribution: Worldwide distribution US Nationwide distribution in the states of CA, IL, MI, NY, OH, SC, and TN. The countries of Austria, France, Germany, Netherlands, Sweden.
• Total Product Life Cycle: TPLC 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.