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Recall Observatory FDA recall evidence

Device product

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

Z-1018-2022

March 09, 2022

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 89896
Status
Terminated
Classification
Class II
Quantity
15 systems
Official record key
device-enforcement:Z-1018-2022

Official wording

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.

Code information: 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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.