Becton, Dickinson and Company (BD Bio Sciences) is recalling 639 kits of BD Trucount Controls (30 Test) because the control kits contain incorrect standard deviation (SD) values for the low and high control beads. This manufacturing error compromises the accurate calculation of bead counts, which can lead to incorrect laboratory test results. The recall affects 10 kits distributed across Tennessee, New York, and Massachusetts, as well as 629 kits distributed internationally.
Incorrect standard deviation values on these controls can lead to inaccurate bead count calculations, potentially resulting in incorrect patient diagnosis or medical management decisions based on laboratory data.
Correction or Replacement
Quantity: 10 kits
Quantity: 629 kits
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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