Skip to content
Recall Observatory FDA recall evidence

Device product

BD Trucount Controls, 30 Test - REF: 340335

Z-2238-2025

July 08, 2025

Class II

Product summary

Firm
Becton, Dickinson and Company, BD Bio Sciences
Event
Event 97141
Status
Ongoing
Classification
Class II
Quantity
629 kits
Official record key
device-enforcement:Z-2238-2025

Official wording

Reason: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

Code information: Lot: 85708 UDI: 00382903403356 *Distributed outside the US

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.