BEUDAMED
    FDA Recall Terminated

    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.

    Recall: Z-3063-2011 · Initiated April 11, 2011

    Recall

    Recall Number
    Z-3063-2011
    Event Number
    59523
    Firm
    Sysmex America, Inc.
    FEI Number
    1000515253
    Product Code
    GGK
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    April 11, 2011
    Posted
    August 23, 2011
    Terminated
    March 14, 2012
    Address
    1 Nelson C White Pkwy, Mundelein, IL, 60060-9528

    Description

    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.

    Reason

    The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.

    Action

    Sysmex America, Inc. sent a "PRODUCT NOTIFICATION" letter dated April 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to discontinue use of the affected SIM lots, and to remove affected lots from their analyzers as soon as possible to avoid long-term performance problems on the analyzer. A Stromatolyser -IM (220-A) Voluntary Recall form was attached for customers to complete and return via fax to Sysmex Customer Service at 800-689-8296. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the notification are directed to the Sysmex Technical Assistance Center at 1-888-879-7639.

    Distribution

    Worldwide Distribution--USA (nationwide and Puerto Rico) and the countries of Canada, Colombia, Ecuador, Mexico, Netherland Antilles and Peru.

    Quantity

    1,887 cubetainers