BEUDAMED
    FDA Recall Terminated

    Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN. For the in vitro quantitative determination of calcium in serum, plasma and urine.

    Recall: Z-1823-2011 · Initiated October 11, 2010

    Recall

    Recall Number
    Z-1823-2011
    Event Number
    57455
    Firm
    Roche Diagnostics Operations, Inc.
    FEI Number
    1823260
    Product Code
    CIC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 11, 2010
    Posted
    March 25, 2011
    Terminated
    September 13, 2011
    Address
    9115 Hague Road, Indianapolis, IN, 46256-1025

    Description

    Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN. For the in vitro quantitative determination of calcium in serum, plasma and urine.

    Reason

    The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401.

    Action

    The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated October 11, 2010 to all consignees/customers via UPS(signature required) . The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the recalled product; discard from inventory according to their site's local regulations; complete and return the attached Faxback form via fax to 1-877-598-5705 even if they do not have the affected product, and file this letter for future reference. The firm added lot 63020401 to the recall in 3/2011. The firm is mailing an URGENT MEDICAL DEVICE REMOVAL notice to customers that purchased that lot of product. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have questions about the information contained in this letter.

    Distribution

    Nationwide distribution.

    Quantity

    13, 405 units