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

FDA Recall #Z-2237-2025 — Class II — July 8, 2025

Recall #Z-2237-2025 Date: July 8, 2025 Classification: Class II Status: Ongoing

Product Description

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

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.

Recalling Firm

Becton, Dickinson and Company, BD Bio Sciences — Milpitas, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

10 kits

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.

Code Information

Lot: 4285713/UDI: 00382906643438

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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