Recall Z-2238-2025— Becton, Dickinson and Company, BD Bio Sciences
Class II · Ongoing
Class II FDA medical device recall by Becton, Dickinson and Company, BD Bio Sciences, initiated 2025-07-08. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Trucount Controls, 30 Test - REF: 340335. Reason: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts..
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-08
- Firm location
- Milpitas, CA, United States
Product description
BD Trucount Controls, 30 Test - REF: 340335
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.