FDA recall Z-1018-2022

Product

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

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.

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.

Key facts

Status

Terminated

Initiation date

2022-03-09

Report date

2022-05-11

Termination date

2024-01-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1018-2022