FDA recall Z-2238-2025

Becton, Dickinson and Company, BD Bio Sciences · Class II · device

Product

BD Trucount Controls, 30 Test - REF: 340335

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.

Key facts

Status: Ongoing
Initiation date: 2025-07-08
Report date: 2025-08-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Milpitas, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2025