—#192826

Product

BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: 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

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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:

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-03-09
Terminated: 2024-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192826. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.