BD FACS Sample Prep Assistant III Recalled for Probe Wear Issues
Becton, Dickinson and Company is recalling 467 units of the BD FACS Sample Prep Assistant III because probes may wear prematurely, causing sample dispensing failures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the source text describes a functional defect (probe wear and clogging) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences, is recalling 467 units of the BD FACS Sample Prep Assistant (SPA) III. The device is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. The recall covers units distributed worldwide, including in the United States and numerous international locations.
The recall was initiated because users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use. When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense. The agency has classified this as a Class II recall.
Users of the BD FACS Sample Prep Assistant III should contact Becton, Dickinson and Company, BD Biosciences, for further instructions on how to proceed with the recall.
The recalled product
- Product
- BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following…
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 467
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)
- Catalog (Ref) No. 647205
Distribution
Part of a larger recall action
This product is one of 3 recalled by Becton, Dickinson and Company, BD Biosciences under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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