BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Summary
The FDA issued a Class II for BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software V by Becton Dickinson & Co.. 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 an.
Details
Source
Device Recall
External ID
Z-1018-2022
Action Date
2022-05-11
Status
Terminated
Category
device
Product Description
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Lot/Code Info: 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
Quantity Affected: 15 systems
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-09
Company
Sparks, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 121 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson & Co.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Co. have FDA actions?
Becton Dickinson & Co. has 73 FDA actions in our database, including 73 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1018-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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