BD Biosciences recalls FACS Sample Prep Assistants II/III for potential probe wear causing sample clogs in flow cytometry. Affected units may need replacement to prevent inaccurate cell counts.
The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.
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Contact the company
📍Recalling firmBecton, Dickinson and Company, BD Biosciences2350 Qume Dr · San Jose, CA 95131-1812
✎ GovInfoNow plain-language explainer
BD Biosciences is recalling FACS Sample Prep Assistant II and III devices because worn probes can cause sample clogs in flow cytometry. This may lead to inaccurate cell counts if the device is used without proper maintenance. Read more at govinfonow.com/recall/67471-bd-facs-sample-prep-assistant-ii-iii-probe-wear-risk.
“BD FACS Sample Prep Assistant II/III: Probe Wear Risk in Flow Cytometry.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67471-bd-facs-sample-prep-assistant-ii-iii-probe-wear-risk. Based on FDA recall #Z-2356-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2356-2020%22&limit=1).
Becton, Dickinson and Company, BD Biosciences recalled the BD FACS Sample Prep Assistant (SPA) II on July 8, 2019, according to the FDA. The device may have probes with unacceptable wear that can clog the probe and result in blocked or inadequate sample dispense.
How to tell if you have it
BD Biosciences
BD FACS Sample Prep Assistant (SPA) II
Catalog No. 337170
95 units
The hazard
The firm confirmed that 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.
Context
GovInfoNow's records show Becton, Dickinson and Company, BD Biosciences has 10 other recalls on record since May 16, 2018. Other recent recalls of similar products include BD Multitest 6-Color TBNK Kit (May 8, 2024), BD Biosciences CD11b APC (Oct. 25, 2023), and BD Multitest 6-Color TBNK Recall (Oct. 3, 2022). Other recent recalls of similar products include Beckman Coulter CellMek SPS Sample Prep System Software Error Risk (Dec. 23, 2025), Hologic Brevera Breast Biopsy Needle Recall (Dec. 15, 2025), and Illumina NextSeq 550Dx Reagent Kits (Oct. 28, 2025).
How to tell if you have this one
Check for the BD FACS Sample Prep Assistant II or III models. The product is used with BD FACSCanto systems and clinical software for lymphocyte subset analysis.
Brand
BD Biosciences
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution including in the states of AL, CO,CT, GA, IL, MA, MI, MD, NC, NH,NJ, NY, OH, PA, TN, TX, VA, and VT. The countries of Australia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Europe, Hong Kong, India, Italy, Jamaica, Japan, Kazakhstan, Malaysia, Martinique, Mexico, New Zealand, Nicaragua, Peru, Puerto Rico (US), Romania, Russia, Singapore, South Africa, South Korea, Swaziland, Switzerland, Turkey, US, Vietnam.
Recall number
Product, codes & lots
Quantity
Z-2356-2020
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 lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.; Catalog (Ref) No. 337170
95 units
Z-2357-2020
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 of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.; Catalog (Ref) No. 650686
51 units
Z-2358-2020
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 previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems; Catalog (Ref) No. 647205
467 units
Based on the official FDA remedy
What to do — step by step
Check Probe Condition
Inspect the probe for signs of wear, such as reduced piercing capability or clogs.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 18 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, CO,CT, GA, IL, MA, MI, MD, NC, NH,NJ, NY, OH, PA, TN, TX, VA, and VT. The countries of Australia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Colorado, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Vermont, Virginia.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2356-2020 (July 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2356-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.