Z-1018-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- March 9, 2022
- Termination Date
- January 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 systems
Product Description
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 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.
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