BEUDAMED
    FDA Recall Terminated

    IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000

    Recall: Z-1316-2014 · Initiated February 3, 2014

    Recall

    Recall Number
    Z-1316-2014
    Event Number
    67586
    Firm
    Siemens Medical Solutions Diagnostics
    FEI Number
    1000122204
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 3, 2014
    Posted
    April 2, 2014
    Terminated
    June 30, 2016
    Address
    62 Flanders-Bartley Rd, Flanders, NJ, 07836-4715

    Description

    IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000

    Reason

    There is a potential for incorrect results to be reported from processing of a sample tube.

    Action

    Siemens sent an Urgent Medical Device Correction letter dated February 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers was told how to correct the issue if it has occurred, and how to prevent the issue from occurring. The completed form should be faxed to (302) 631-7597. Any questions can be directed to Siemens Technical Support Representative. Siemens plans to implement a correction at a later time.

    Distribution

    Nationwide and Foreign Distribution.

    Quantity

    1006 units