BEUDAMED
    FDA Recall Terminated

    IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650

    Recall: Z-2195-2010 · Initiated May 21, 2010

    Recall

    Recall Number
    Z-2195-2010
    Event Number
    55787
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JQX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 21, 2010
    Posted
    August 10, 2010
    Terminated
    May 22, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650

    Reason

    Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots of IMMAGE BUF1. Some lots of BUF1 have been reported to cause high shifts in recovery of control or patient samples. Quality Control failures may result after replacing BUF1 with a different lot.

    Action

    Beckman Coulter will send a Product Corrective Action (PCA) letter on the week of April 19, 2010 to the affected customers. The letter provided the customers with an explanation of the problem and a work around.

    Distribution

    Worldwide: U.S., Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Iceland, Ireland, Italy, Japan, Liechtenstein, Macao, Malaysia, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey and United Kingdom,

    Quantity

    1309