Recall – New software version overwrites custom antibiotic codes

Company: Becton Dickinson & Co.
Date of Enforcement Report: 5/11/2022
Class II

PRODUCT

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

Recall Number:

Z-1018-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

Becton Dickinson & Co. on 3/9/2022. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

15 systems

DISTRIBUTION

U.S. Nationwide and International

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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