FDA Enforcement
Class II
Ongoing
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Recall: Z-2237-2025
·
Reported August 13, 2025
Enforcement
- Recall Number
- Z-2237-2025
- Event ID
- 97141
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton, Dickinson and Company, BD Bio Sciences
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 13, 2025
- Initiation Date
- July 8, 2025
- Classification Date
- August 1, 2025
- Address
- 155 N Mccarthy Blvd, N/A, Milpitas, CA, 95035-5102, United States
Description
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
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 Info
Lot: 4285713/UDI: 00382906643438
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.
Quantity
10 kits