BEUDAMED
    FDA Recall Terminated

    IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

    Recall: Z-0569-2014 · Initiated November 6, 2013

    Recall

    Recall Number
    Z-0569-2014
    Event Number
    66713
    Firm
    Siemens Healthcare Diagnostics
    FEI Number
    2432235
    Product Code
    CGN
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    November 6, 2013
    Posted
    December 24, 2013
    Terminated
    March 23, 2017
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

    Reason

    potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached.

    Action

    Siemens sent an Urgent Medical Device Correction notices dated November 7 2013, via FedEx to the US customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers are instructed that If the adjustment slope is less than or equal to 1.8 and quality control results are within the established ranges, the kit may be used to generate patient results. If the adjustment slope is greater than 1.8, customers are instructed to discontinue use and discard the kit lots. Ex-US distribution is determined at the country level. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions. For further questions please call CUSTOMER CARE CENTER NUMBER: (302) 631-7597.

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of Argentina, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Republic, Estonia, France, Germany, Great Britain, Greece, Guatemala, Hungary, India, Italy, Latvia, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Tunisia, United Arab Emirates, Uzbekistan and Venezuela.

    Quantity

    Domestic: 442 kits; Foreign: 680 kits