BD FACS Sample Prep Assistant II Upgrade Recalled for Probe Wear
Becton, Dickinson and Company is recalling 51 units of the BD FACS Sample Prep Assistant II Upgrade due to premature probe wear that may cause sample dispensing issues.
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. The hazard involves mechanical wear leading to sample dispensing issues, which is a low-risk contamination or functional defect without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences is recalling 51 units of the BD FACS Sample Prep Assistant (SPA) II Upgrade, Catalog No. 650686. The product is an in vitro diagnostic device used with the BD FACSCanto system for the identification and enumeration of lymphocyte subsets in human cells.
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 affected units were distributed worldwide, including nationwide in the United States and in numerous international locations. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these units.
The recalled product
- Product
- BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration…
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 51
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. 650686
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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