BD FACS 7-Color Setup Beads Recall Due to Spectral Overlap Factors Error
Becton Dickinson is recalling BD FACS 7-Color Setup Beads (Ref 666289) due to errors in the spectral overlap factors table that may affect accurate instrument calibration. The recall involves 278 units distributed across the US and internationally.
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: This is a Class II recall involving a technical documentation error in the spectral overlap factors table with no reported illnesses, injuries, or confirmed diagnostic errors. Per the rubric, Class II recalls without hospitalization reports and with theoretical hazards score as Moderate.
Plain-English summary
Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (Ref 666289), a medical device used in flow cytometry for fluorescence compensation and instrument calibration. The recall involves 278 units distributed across multiple US states, Puerto Rico, and numerous international countries. Lot numbers 85637 and 85638 are affected.
The recall is due to errors in the spectral overlap factors table provided with the beads. These errors may affect accurate setup of the flow cytometry instrument prior to analyzing samples, potentially compromising the accuracy of diagnostic results.
No illnesses or injuries have been reported. Facilities and laboratories using affected lot numbers should verify their product lot numbers and contact Becton Dickinson for corrected documentation, replacement product, or additional guidance.
The recalled product
- Product
- REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
- Manufacturer
- Becton, Dickinson and Company, BD Bio Sciences
- Hazard
- calibration-error
- documentation-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 # 85637 & 85638/ UDI: 382906662897
Distribution
Distribution scope not specified by the agency.
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