BD Trucount Controls Lot 85708 Recalled for Incorrect SD Values
BD Trucount Controls (Lot 85708) are being recalled due to incorrect standard deviation values that could compromise laboratory test accuracy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device recall announced proactively with no reported illnesses or injuries. The controls contain incorrect standard deviation values that could compromise laboratory test accuracy verification.
Plain-English summary
BD Trucount Controls, 30 Test (REF: 340335), Lot 85708 are being recalled due to incorrect standard deviation (SD) values in the control beads. Becton, Dickinson and Company, BD Bio Sciences determined that the control kits contain incorrect SD values for the low and high control beads, which compromises the accurate calculation of bead counts.
Approximately 629 kits were distributed worldwide. In the United States, distribution was limited to Tennessee, New York, and Massachusetts. International distribution included Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, and the United Kingdom. The affected lot number is 85708 with UDI 00382903403356.
The recalled product
- Product
- BD Trucount Controls, 30 Test - REF: 340335
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Hazard
- quality-defect
- measurement-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 85708 UDI: 00382903403356 *Distributed outside the US
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03