BD FACS 7-Color Setup Beads Recalled Due to Spectral Overlap Errors
Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (REF 666289, Lots 85637 and 85638) because errors in the spectral overlap factors table may prevent accurate setup of flow cytometry instruments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a diagnostic device where errors could affect instrument setup and sample analysis reliability. Although no illnesses or injuries are explicitly reported, the risk-of-harm from inaccurate flow cytometry calibration in a diagnostic context qualifies as High severity.
Plain-English summary
Becton, Dickinson and Company, BD Bio Sciences, is recalling BD FACS 7-Color Setup Beads (REF 666289, Lot numbers 85637 and 85638) used in flow cytometry for fluorescence compensation. The recall involves 278 units distributed across multiple U.S. states, Puerto Rico, and numerous international locations including Canada, Mexico, Australia, Japan, and others.
The product is being recalled due to 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 analyzing samples, potentially compromising the reliability of instrument calibration.
Customers who have received this product should contact Becton, Dickinson and Company for guidance on how to proceed. The product is identified by UDI 382906662897 and lot numbers 85637 and 85638.
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
- data-accuracy
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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