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 product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

    Recall: Z-2797-2011 · Initiated June 23, 2009

    Recall

    Recall Number
    Z-2797-2011
    Event Number
    58916
    Firm
    Sysmex America, Inc.
    FEI Number
    1000515253
    Product Code
    GGK
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    June 23, 2009
    Posted
    July 13, 2011
    Terminated
    July 13, 2011
    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 product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

    Reason

    The affected lots of Stromatolyser-IM lysing reagent was 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 "MEDICAL DEVICE RECALL" letter dated June 2009 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 at 800-218-2711. The form will be used to place orders to replace the affected product. Any questions concerning the information contained in the recall letter are directed to the Sysmex Technical Assistance Center at 1-888-879-7639. The firm sent a second notice to non-responding accounts on September 14, 2009. A copy of the June 26, 2009 recall letter and the fax back form were included with the letter. The customers were informed that Sysmex had not received their completed fax back form and were requested to respond to confirm the notification was received.

    Distribution

    Worldwide Distribution--USA (nationwide) and the countries of Brazil, Canada and Honduras.

    Quantity

    4,005 cubetainers