FDA Medical devices recall ·
BD Trucount Controls, 30 Test recall
- Recall number
- Z-2238-2025
- Date
- (initiated July 8, 2025)
- Company / brand
- Becton, Dickinson and Company, BD Bio Sciences
155 N Mccarthy Blvd, Milpitas, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 629 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD Trucount Controls, 30 Test - REF: 340335
Why was it recalled?
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 85708 UDI: 00382903403356 *Distributed outside the US
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: Massachusetts New York Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2238-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.