BD FACS setup beads have errors in spectral overlap factors table
BD FACS 7-Color Setup Beads are being recalled because errors in the spectral overlap factors table may affect accurate setup of the flow cytometry instrument. 590 units affected.
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 recall of a laboratory setup reagent where the source states only that instrument setup may be affected, with no clinical consequence quantified.
Plain-English summary
BD FACS 7-Color Setup Beads, REF 335775, 25 setups per kit, prescription only, for in vitro diagnostic use, are being recalled. The beads are used in flow cytometry for fluorescence compensation. The action covers 590 units.
According to the manufacturer, following customer complaints, errors in the spectral overlap factors table for the 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples. The FDA classified the action as Class II.
Affected lots are 85612 and 85613, UDI 382903357758. Distribution was across a large number of US states and Puerto Rico.
Laboratories should identify affected stock using the REF, UDI and lot numbers above and follow the instructions issued by the manufacturer.
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
- spectral-overlap-error
- instrument-setup
- flow-cytometry
- class-ii
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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