Device product

BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

Z-2237-2025

July 08, 2025

Class II

Product summary

Firm: Becton, Dickinson and Company, BD Bio Sciences
Event: Event 97141
Status: Ongoing
Classification: Class II
Quantity: 10 kits
Official record key: device-enforcement:Z-2237-2025

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: 4285713/UDI: 00382906643438

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.