BD Trucount Controls, 30 Test - REF: 340335
Summary
The FDA issued a Class II for BD Trucount Controls, 30 Test - REF: 340335 by Becton, Dickinson and Company, BD Bio Sciences. Reason: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead co.
Details
Source
Device Recall
External ID
Z-2238-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
BD Trucount Controls, 30 Test - REF: 340335
Lot/Code Info: Lot: 85708 UDI: 00382903403356 *Distributed outside the US
Quantity Affected: 629 kits
Reason for Recall
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Distribution
Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-08
Company
Milpitas, CA
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 172 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton, Dickinson and Company, BD Bio Sciences has 10 FDA actions in our database, including 10 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 and Company, BD Bio Sciences) 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 and Company, BD Bio Sciences have FDA actions?
Becton, Dickinson and Company, BD Bio Sciences has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2238-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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