Medical Device Recall: BD Trucount Controls, 30 Test - REF: 340335
Becton, Dickinson and Company, BD Bio Sciences · July 8, 2025
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.
States Affected
NATIONWIDE
Quantity Affected
629 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2238-2025
Status: ongoing
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