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U.S. Department of Health and Human Services

Class 2 Device Recall BD Synapsys Microbiology Informatics Solution

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  Class 2 Device Recall BD Synapsys Microbiology Informatics Solution see related information
Date Initiated by Firm February 21, 2019
Create Date March 23, 2019
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-1051-2019
Recall Event ID 82225
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product 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.
Code Information BD Synapsys version 2.1  UDI: 00382904441500  
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact
410-316-4258
Manufacturer Reason
for Recall		 BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
FDA Determined
Cause 2		 Software design
Action BD notified Synapsys Customer via letter UPS on 02/21/19 identified problem and action taken. Customer sites were updated remotely with a database update on January 10, 2019. Accounts asked to complete and return the CUSTOMER RESPONSE FORM BD Synapsys. The issue will be resolved by the software update syngo CT VB10A_SP1 (Service Pack 1) as soon as the update is available. For questions contact BD Customer/Technical Support at 8006388663. For customers outside the US, contact your local BD representative or distributor.
Quantity in Commerce 5 sites
Distribution Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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