FDA Medical devices recall ·
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only… recall
- Recall number
- Z-2078-2025
- Date
- (initiated June 3, 2025)
- Company / brand
- Becton, Dickinson and Company, BD Bio Sciences
155 N Mccarthy Blvd, Milpitas, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 590 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 85612 & 85613/ UDI: 382903357758
Distribution
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:
States: 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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2078-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.