BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Reported: August 13, 2025 Initiated: July 8, 2025 #Z-2237-2025
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.
Details
- Recalling Firm
- Becton, Dickinson and Company, BD Bio Sciences
- Units Affected
- 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.
- Location
- Milpitas, CA
Frequently Asked Questions
What product was recalled? ▼
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD. Recalled by Becton, Dickinson and Company, BD Bio Sciences. Units affected: 10 kits.
Why was this product recalled? ▼
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 13, 2025. Severity: Moderate. Recall number: Z-2237-2025.
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