Class 2 Device Recall BD Synapsys

• Date Initiated by Firm: June 08, 2023
• Date Posted: July 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2099-2023
• Recall Event ID: 92406
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: BD Synapsys Informatics Solution, Catalog Number 444150
• Code Information: UDI-DI: 00382904441500
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• Manufacturer Reason for Recall: There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.
• FDA Determined Cause: Software design
• Action: An URGENT: Medical Device Product Correction notification letter dated 6/8/23 was sent to customers. Please Take the Following Actions: 1) Read and understand the contents of this letter and return the Customer Response form clearly indicating the applicable contact person at your facility to support the assessment and arrangement of remote service of the BD Synapsys" informatics software. 2) BD Synapsys" Informatics software can continue to be used. However, when running tests and evaluating cultures, confirm the Accession number matches the Breadcrumb Navigation Menu. If the Accession number in the Patient Information Panel does not match the Accession number in the Breadcrumb Navigation Menu, wait until the demographics load and contact BD using the contact information provided below. (Reference Attachment 1) 3) A review of prior reported results is not deemed to be necessary. 4) Share and post this recall letter within your facility network and ensure users are aware of the information included this communication. 5) 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: 1-00-FDA-1088 (1-800-332-1088) Actions Taken by BD: 1) BD is working on an interim solution and will contact your facility in order to assess and arrange a remote service, where applicable, to the BD Synapsys" Informatics software to reduce the risk of demographics mis-association. 2) A corrective and preventive action was initiated to confirm root cause and identify actions to prevent reoccurrence. Contact Information: If you require further assistance, please contact: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
• Quantity in Commerce: 102 systems
• Distribution: US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI. Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.