Device product
BD Trucount Controls, 30 Test - REF: 340335
Z-2238-2025
Product summary
- Event
- Event 97141
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 629 kits
- Official record key
device-enforcement:Z-2238-2025
Official wording
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 information: Lot: 85708 UDI: 00382903403356 *Distributed outside the US
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.
Derived failure modes
-
Unknown
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.