BEUDAMED
    FDA Recall Terminated

    AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including the detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.

    Recall: Z-0056-2013 · Initiated April 11, 2012

    Recall

    Recall Number
    Z-0056-2013
    Event Number
    63155
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    April 11, 2012
    Posted
    October 12, 2012
    Terminated
    February 11, 2013
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including the detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.

    Reason

    The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) units which can cause misidentification of a sample when software versions lower than version 4.1 is used.

    Action

    Beckman Coulter initiated an Urgent Product Correction letter dated April 11, 2012, with attached PCA Response Form to all customers who purchased the affected product. . The letter identified the product, the problem, and the action taken by the customer. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers with questions were instructed to contact their local Beckman Coulter representative. Customers with questions should call 714-993-5321. For questions regarding this recall call 714-961-4941.

    Distribution

    Worldwide Distribution - USA (nationwide) and the following countries: Argentina Australia Austria Belarus Belgium China Croatia Czech Republic Denmark Finland France Germany Hungary India Ireland Israel Italy Japan Korea, Republic of Kuwait Macao Malaysia Netherlands New Zealand Norway Panama Russian Federation Slovakia Slovenia South Africa Spain Sweden Switzerland Turkey United Kingdom

    Quantity

    468 units total (51 units in US)