Becton, Dickinson and Company, BD Biosciences recalls CD11b APC: ASR, REF: 340936, and CE, REF: 333143

Recall date

October 25, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0641-2024

FDA classification

Class II

Brand / firm

Becton, Dickinson and Company, BD Biosciences

Sold / distributed

Worldwide - US Nationwide distribution including in the states of IL, MN, FL, MI, MD, NC, NY, CA, GA, AR, KS, PA, NH, TX, OK, MA, MO, DC, AZ, IN, NJ, TN, WA, VA, CT and the countries of CA, BE, SG, HK, TW, BR, MY, IN, BO, PE, JP, MX, CL, KR, UY, AU.

Why it was recalled

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

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

What was recalled

CD11b APC: ASR, REF: 340936, and CE, REF: 333143