Z-1051-2019 Class II Terminated
FDA device recall Z-1051-2019 was initiated by Becton Dickinson & Co. on February 21, 2019 and is designated Class II. Reason for recall: BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record. The recall status is terminated (terminated April 17, 2020). Affected quantity: 5 sites.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 21, 2019
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 sites
Product Description
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments.
Reason for Recall
BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
Distribution Pattern
Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands
Code Information
BD Synapsys version 2.1 UDI: 00382904441500