Z-2356-2020Class II

BD FACS Sample Prep Assistant (SPA) II -

Name: Z-2356-2020 BD FACS Sample Prep Assistant (SPA) II -
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2019-07-08
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2019-07-08 / Terminated / root cause: design

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of 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... on 2019-07-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2356-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-08
Posted: 2020-06-11
Terminated: 2023-01-31
Recalling firm: Becton, Dickinson and Company, BD Biosciences
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 lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
Product code: PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
Action: The recall was initiated by customer letter dated July 8th, 2019 via UPS/FEDEX and email. The following actions are to be taken: Follow the FACS Sample Prep Assistant II or III System Instructions for Use (IFU) directions for inspecting the probe daily for wear as part of the daily startup procedure. For both SPA II and III IFUs, this may be found in Chapter 5. Instructions for replacing the probe can be located in the Shutdown and Maintenance chapter of the IFU. For SPA II this may be found in Chapter 7. For SPA III this may be found in Chapter 6. The following provides additional detail regarding the probe inspection process: 1. Visually check the probe for signs of wear (the probe is no longer straight or the Teflon coating is gone). Note: the probe does not need to be removed from the system for this inspection. 2. Replace and discard the probe in accordance with the IFU if the probe shows signs of unacceptable wear. Report any adverse health consequences experienced with the use of this product . Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch, Phone: 1-800-FDA-1088 (1-800-332-1088). For further assistance, contact Customer Support at 855236-2772 (prompt 2), and for customers outside the US , contact the local representative or distributor.
Quantity in commerce: 95 units
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.
Product codes and lots: Catalog (Ref) No. 337170

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2356-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2356-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-11
Z-2357-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-11
Z-2358-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-11

Product code PER

K050191Class IModification to Bd Facscanto System with Bd Facscanto Clinical SoftwareBecton, Dickinson & CO / cleared 2005-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)