BD Trucount Absolute Counting Tubes Recalled for Lot Mixing
Becton, Dickinson and Company is recalling one lot of BD Trucount tubes because some pouches may contain tubes from a different lot, presenting a low risk to patient safety.
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: The source text explicitly states that the issue presents a 'low risk to patient safety or impact to data,' which aligns with the rubric criteria for a Moderate severity score involving low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences is recalling one lot of BD Trucount Absolute Counting Tubes, Model number 340334 IVD. The recall involves 1,743 units, distributed to 467 locations in the United States and 1,276 locations internationally. The affected manufacturing lot is 534964.
The recall was initiated because some pouches within the affected lot may contain tubes from another lot. This mixing results in a 3.3% difference in bead counts between the two lots. The manufacturer states that this discrepancy presents a low risk to patient safety or impact to data if the product is used.
The product is used for determining absolute counts of leucocytes in blood and is designed for use with in vitro diagnostic products such as BD Tritest reagents and a suitably equipped flow cytometer. The recall covers distribution in the US (including MD, CA, GA, WA, PA, CO, TN, FL, NC, DE, VA, CT, LA, NY, OH, MN, and NH) and internationally to China, Japan, and India.
The recalled product
- Product
- BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flo
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Hazard
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 (2)
- Model: 340334
- Manufacaturing lot: 534964
Distribution
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