FDAMarch 31, 2016device

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 flow cytometer. BD Trucou...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.

What to do

FDA enforcement status: Terminated

Brands named

becton dickinson and company bd biosciencesbectonbecton dickinson

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 flow cytometer. BD Trucou... — Recall Details · AllClear