BD Trucount 664343 control kits carry incorrect standard deviation values
BD Trucount Controls 30 Test kits, REF 664343, are being recalled because they contain incorrect standard deviation values for the low and high control beads. 10 kits are 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 664343, prescription only, for in vitro diagnostic use, UDI 00382906643438, is being recalled. The action covers 10 kits from lot 4285713.
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.
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: 664343, RxOnly, IVD
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Hazard
- incorrect-value-assignment
- quality-control
- bead-count
- class-ii
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: 4285713/UDI: 00382906643438
Distribution
Distributed nationwide across the United States.
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