Reported Aug 13, 2025 · Ongoing
BD Trucount Controls, 30 Test - REF: 340335
Becton, Dickinson and Company, BD Bio Sciences
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton, Dickinson and Company, BD Bio Sciences · 155 N Mccarthy Blvd · Milpitas, CA · 95035-5102
Is this the product you have?
- BD Trucount Controls, 30
- Test - REF340335
- Lot codes and dates
- Lot85708
- UDI00382903403356 *Distributed outside the US
- Amount recalled
- 629 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Becton, Dickinson and Company, BD Bio Sciences recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.