Summary
The FDA issued a Class II for BD Synapsys Informatics Solution, Catalog Number 444150 by Becton Dickinson & Co.. Reason: There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) i.
Details
Source
Device Recall
External ID
Z-2099-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
BD Synapsys Informatics Solution, Catalog Number 444150
Lot/Code Info: UDI-DI: 00382904441500;
Quantity Affected: 102 systems
Reason for Recall
There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.
Distribution
US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI. Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-08
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 287 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-2099-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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