BD Trucount control kits carry incorrect standard deviation values for beads
BD Trucount Controls 30 Test kits are being recalled because they contain incorrect standard deviation values for the low and high control beads, which compromises accurate bead count calculation. 629 kits affected.
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 recall of a laboratory control material with incorrect assigned values, with no patient result or clinical consequence stated.
Plain-English summary
BD Trucount Controls, 30 Test, REF 340335, UDI 00382903403356, is being recalled. The action covers 629 kits from lot 85708.
The stated reason is that the control kits contain incorrect standard deviation values for the low and high control beads, which compromises the accurate calculation of bead counts. The FDA classified the action as Class II. The source does not describe a patient result consequence.
Distribution was worldwide, including nationwide in the United States in Tennessee, New York and Massachusetts among other states, and outside the US.
Laboratories should identify affected stock using the REF, UDI and lot number above and follow the instructions issued by BD.
The recalled product
- Product
- BD Trucount Controls, 30 Test - REF: 340335
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Affected units
- 629
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
Part of a larger recall action
This product is one of 2 recalled by Becton, Dickinson and Company, BD Bio Sciences under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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