Medical device recalls Moderate risk

Becton, Dickinson and Company, BD Biosciences recalls BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leu…

Recall date
June 24, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2252-2016
FDA classification
Class II
Brand / firm
Becton, Dickinson and Company, BD Biosciences
Sold / distributed
USA Distribution to the states of : NC, WA, WI, NJ, PR, MD, NY, MA, CA, NY , MD, KY, IN, VA, SD, PA, OH, AR, AZ and Foreign to : Canada, Belgium and Chile

Why it was recalled

One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.

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