Z-2237-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- July 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 kits
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.
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.
Code Information
Lot: 4285713/UDI: 00382906643438