# FDA recall Z-2079-2025

> **Becton, Dickinson and Company, BD Bio Sciences** · Class II · device recall initiated 2025-06-03.

## Product

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

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:

## Key facts

- **Recall number:** Z-2079-2025
- **Recalling firm:** Becton, Dickinson and Company, BD Bio Sciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-03
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milpitas, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2079-2025

## Citation

> AI Analytics. FDA recall Z-2079-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2079-2025. Source: US FDA. Licensed CC0.

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