BEUDAMED
    FDA Recall Open, Classified

    BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

    Recall: Z-0009-2025 · Initiated August 12, 2024

    Recall

    Recall Number
    Z-0009-2025
    Event Number
    95215
    Firm
    Becton, Dickinson and Company, BD Bio Sciences
    FEI Number
    3027394506
    Product Code
    PER
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    August 12, 2024
    Posted
    October 3, 2024
    Address
    155 N Mccarthy Blvd, Milpitas, CA, 95035-5102

    Description

    BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

    Reason

    Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.

    Action

    On 8/12/2024, correction notices were sent to customers who were informed of the following; 1) Cease use of the sample preparation system with software version 1.4.1. until the Multidispense feature has been disabled. Patient samples can be prepared using single dispense on the sample preparation system or manually. 2) It is recommended that laboratories upgrade affected sample preparation systems to version 1.4.2 to correct the issue as soon as it is available. 3) Ensure the contents of this notification are read and understood by those within your organization. 4) Complete and return the response form via email to [email protected] If you require further assistance, contact: 1-844-823-5433, Mon-Fri 8:00am and 5:00pm CT or email [email protected]. Recall related questions can be emailed to [email protected]

    Distribution

    US: NJ, UT, WI, TX, ID, AK, MN, MA, MD, TN, MI, CA, VA OUS: Ireland, Austria, Italy, Germany, Belgium, Finland, Canada, France, Spain, New Zealand, United Kingdom, Japan, Australia, Norway, Singapore, Sweden, Turkey, Brazil, Colombia, Netherlands, United Arab Emirates, Saudi Arabia, Mexico, Switzerland, Costa Rica, China, Azerbaijan, Algeria, Jordan, India

    Quantity

    130