BD Synapsys Microbiology Informatics Solution, Catalog… recallZ-1018-2022 · Becton Dickinson & Co. · initiated Mar 9, 2022
Terminated
Is my device affected?
- 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.
- 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.
- 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
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 root cause category: Under Investigation by firm
What the company is doing
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:
Recall details
- Recall number
- Z-1018-2022
- Status
- Terminated
- Initiated by the company
- Mar 9, 2022
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 15 systems
- Product code
- JQP
- 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.
Product description
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Synapsys™ Informatics Solution 444150Becton, Dickinson And Company · Calculator/data processing module, for clinical use5 recalls81 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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