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Becton, Dickinson and Company, BD Biosciences recalls BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping
Recalled December 16, 2020 · FDA recall Z-0562-2021 · Becton, Dickinson and Company, BD Biosciences
Hazard
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating. · FDA Class II
Units
619 vials
Sold at
Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, PR, RI, SD, TN, TX, and VA. The countries of Canada, Belgium, Korea, India, Ecuador, Japan, Costa Rica, Australia, Vietnam, Pakistan, Singapore, Thailand, and Peru.
Description
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Product
BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
Manufacturer(s)
Becton, Dickinson and Company, BD Biosciences
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →