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U.S. Department of Health and Human Services

Class 2 Device Recall BD Synapsys

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 Class 2 Device Recall BD Synapsyssee related information
Date Initiated by FirmJune 08, 2023
Date PostedJuly 06, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2099-2023
Recall Event ID 92406
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductBD 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 2
Software design
ActionAn 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 Commerce102 systems
DistributionUS 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 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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