BD Trucount Controls recall
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Why was BD Trucount Controls recalled?
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 4285713/UDI: 00382906643438
- Product
- BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences
- Quantity
- 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.
- Recall date
- August 13, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)