BD Trucount Tubes Recalled for Potential Sealing Defects
Becton, Dickinson and Company is recalling one lot of BD Trucount Absolute Counting Tubes because they may not be sealed properly, which can degrade product performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the hazard involves performance degradation rather than direct physical injury or reported illness, fitting the criteria for a moderate severity recall.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences is recalling one lot of BD Trucount Absolute Counting Tubes (IVD), catalog number 340334. These tubes are used for determining absolute counts of leucocytes in blood.
The recall was initiated because the tubes may not be sealed properly. Exposure to the ambient environment can rapidly degrade the performance of the product. The affected lot is identified by lot number 6083708 and embossing ID 160216T3.
The recall involves 328 units distributed in the United States and 516 units distributed internationally. US distribution included the states of NC, WA, WI, NJ, PR, MD, NY, MA, CA, KY, IN, VA, SD, PA, OH, AR, and AZ. International distribution included Canada, Belgium, and Chile. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
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 (3)
- Catalog 340334
- Lot
- 6083708 (embossing ID of (160216T3)
Distribution
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