Becton, Dickinson and Company, BD Bio Sciences: Medical Device Recall in 2025 - (Recall #: Z-2237-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 8, 2025

Date Posted: August 13, 2025

Recall Number: Z-2237-2025

Event ID: 97141

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.

Status: Ongoing

Product Quantity: 10 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated