Z-2079-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- June 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 278 units
Product Description
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Reason for Recall
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.
Distribution Pattern
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:
Code Information
Lot # 85637 & 85638/ UDI: 382906662897