BD FACS Sample Prep Assistant II Recalled for Probe Wear Issues
Becton, Dickinson and Company is recalling 95 units of the BD FACS Sample Prep Assistant II 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. The hazard involves equipment malfunction leading to inadequate sample dispense, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences is recalling 95 units of the BD FACS Sample Prep Assistant (SPA) II. The recall is due to a defect where users may encounter probes with unacceptable wear before reaching the 2,500 piercings guideline specified in the Instructions for Use (IFU).
When the probe wears prematurely, particles from the rubber cap are more likely to clog the probe. This clogging results in blocked or inadequate sample dispense, which can affect the performance of the in vitro diagnostic device used for flow cytometry.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Users of the BD FACS Sample Prep Assistant II and III should check their equipment for signs of probe wear and contact the recalling firm for further instructions.
The recalled product
- Product
- BD FACS Sample Prep Assistant (SPA) II - 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 of…
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 95
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. 337170
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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