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BD Synapsys Informatics Solution, Catalog Number 444150 recallZ-2099-2023 · Becton Dickinson & Co. · initiated Jun 8, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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: [email protected]

Recall details

Recall number
Z-2099-2023
Status
Open, Classified
Initiated by the company
Jun 8, 2023
Posted by the FDA
Jul 6, 2023
Recalling firm
Becton Dickinson & Co.
Quantity
102 systems
Product code
JQP
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

Product description

BD Synapsys Informatics Solution, Catalog Number 444150

Code information (models, lots, serial numbers)

UDI-DI: 00382904441500;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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