BD Trucount Control Kit Recalled for Incorrect Standard Deviation Values
Becton, Dickinson is recalling BD Trucount Control kits with incorrect standard deviation values that compromise the accurate calculation of bead counts. The recall affects kits distributed worldwide including the United States.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is incorrect control bead standard deviation values that compromise measurement accuracy. Per the rubric, when illnesses are not reported and the hazard is theoretical, the score is at most 3.
Plain-English summary
Becton, Dickinson and Company, BD Bio Sciences, is recalling BD Trucount Controls, 30 Test (REF: 664343) due to incorrect standard deviation (SD) values in the control beads. The SD values are used in the calculation of bead counts for quality control purposes. The incorrect values compromise the accuracy of these critical calculations.
The affected product (lot 4285713) has been distributed worldwide, including throughout the United States in Tennessee, New York, and Massachusetts, and internationally in Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, and the United Kingdom.
The recalled product
- Product
- BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Hazard
- calibration-error
- 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: 4285713/UDI: 00382906643438
Distribution
Distributed nationwide across the United States.
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