Becton Dickinson & Co. BD Synapsys Informatics Solution, Catalog Number 444150 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD Synapsys Informatics Solution, Catalog Number 444150
Brand
Becton Dickinson & Co.
Lot Codes / Batch Numbers
UDI-DI: 00382904441500
Products Sold
UDI-DI: 00382904441500;
Becton Dickinson & Co. is recalling BD Synapsys Informatics Solution, Catalog Number 444150 due to 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) i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, IL, IA, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI
Page updated: Jan 10, 2026