BD FACS Setup Beads Recall Due to Spectral Overlap Factors Table Errors
Becton Dickinson is recalling BD FACS 7-Color Setup Beads because the spectral overlap factors table contains errors that may affect flow cytometry instrument calibration and setup.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The hazard is an error in reference data (spectral overlap factors table) that may affect instrument calibration. The impact is operational accuracy rather than direct patient safety harm.
Plain-English summary
Becton Dickinson and Company, BD Bio Sciences, is recalling BD FACS 7-Color Setup Beads (REF: 335775), 25 setups per kit. The product is a medical device used in flow cytometry for fluorescence compensation and instrument calibration. Approximately 590 units with lot numbers 85612 and 85613 (UDI: 382903357758) are involved in this recall.
The recall was initiated following customer complaints regarding errors in the spectral overlap factors table for the 7-color setup beads. These errors may affect the accurate setup of flow cytometry instruments prior to sample analysis, potentially impacting instrument calibration.
The affected beads have been distributed throughout the United States (including Puerto Rico and the District of Columbia) and internationally to 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, and Taiwan. Healthcare facilities and clinical laboratories in these regions may have received affected units.
The recalled product
- Product
- REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Hazard
- mis-labeling
- calibration-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 85612 & 85613/ UDI: 382903357758
Distribution
Distribution scope not specified by the agency.
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