BEUDAMED
    FDA Recall Terminated

    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.

    Recall: Z-0341-2016 · Initiated September 3, 2015

    Recall

    Recall Number
    Z-0341-2016
    Event Number
    72288
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 3, 2015
    Posted
    November 25, 2015
    Terminated
    November 30, 2017
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.

    Reason

    These Lot numbers are not stable up to the expiry date on the product labeling.

    Action

    Leica sent a MEDICAL DEVICE RECALL NOTIFICATION letter dated September 3, 2015 via mail to all of the consignees. The letter identified the affected, product, problem and actions to be taken. Customers are instructed to discontinue use of the reagent lots listed in the recall notification. It is requested that customers appropriately destroy any unused or partially used affected lots of the reagent, and indicate on the attached Medical Device Recall Notification Acknowledgement Form that this action has been undertaken. Customers were asked to confirm receipt of the notice as soon as possible by signing and dating the attached Medical Device Recall Notification Acknowledgement Form and fax it back to1-847-236-3747, to receive your alternative replacement for applicable orders. For questions contact your local Leica representative.

    Distribution

    Worldwide Distribution - US Nationwide, Australia, Austria, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Netherlands, Norway, Romania, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland and UK.

    Quantity

    U.S: 1 unit of CD10-270-CE-S & 66 units of CD10-270-CE. Foreign: 83 units of CD10-270-CE-S & 219 units of CD10-270-CE