Summary
The FDA issued a Class II for BD COR System Software. Model Number: 444829. by Becton Dickinson & Co.. Reason: Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results..
Details
Source
Device Recall
External ID
Z-2162-2025
Action Date
2025-07-30
Status
Ongoing
Category
device
Product Description
BD COR System Software. Model Number: 444829.
Lot/Code Info: Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Quantity Affected: 7 systems
Reason for Recall
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Distribution
Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-23
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 122 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-2162-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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