Z-1018-2022Class II

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

Name: Z-1018-2022 BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Creator: Becton Dickinson & Co.
Published: 2022-03-09
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-03-09 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10 on 2022-03-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1018-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-09
Posted: 2022-04-29
Terminated: 2024-01-19
Recalling firm: Becton Dickinson & Co
Product: BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: 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: Under Investigation by firm
Action: 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:
Quantity in commerce: 15 systems
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1018-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1018-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-11	2022-04-29

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)