FDAFDA · Food and drugs·Recall number Z-2237-2025
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Published August 13, 2025 · Recall initiated: July 8, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Distributor
- 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.
- Lot
- Lot: 4285713/UDI: 00382906643438
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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