Z-1018-2022 Class II Terminated
FDA device recall Z-1018-2022 was initiated by Becton Dickinson & Co. on Mar 9, 2022 and is designated Class II. 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. The recall status is terminated (terminated Jan 19, 2024). Affected quantity: 15 systems.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- Mar 9, 2022
- Termination Date
- Jan 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1018-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026