Home / Recalls / Medical Devices
Becton, Dickinson and Company, BD Bio Sciences recalls REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence com
Recalled July 9, 2025 · FDA recall Z-2078-2025 · Becton, Dickinson and Company, BD Bio Sciences
Hazard
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples. · FDA Class II
Units
590 units
Sold at
US: Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Hong Kong, India, Japan, South Korea, Mexico, Malaysia, Nepal, New Zealand, Peru, Pakistan, Singapore, El Salvador, Taiwan OUS:
Description
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
Product
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
Manufacturer(s)
Becton, Dickinson and Company, BD Bio Sciences
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →