BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.

    Recall: Z-2352-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2352-2016
    Event ID
    74764
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ORTHO-CLINICAL DIAGNOSTICS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 17, 2016
    Initiation Date
    July 14, 2016
    Classification Date
    August 5, 2016
    Termination Date
    June 8, 2018
    Address
    FELINDRE MEADOWS, Bridgend, N/A, United Kingdom

    Description

    VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.

    Reason

    Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug Fulvestrant and theVITROS Immunodiagnostic Estradiol Reagent assay. The firm conducted an internal investigation and was able to confirm biased positive (ranging from 1303-4046%) on Estradiol results, obtained from postmenopausal females taking Fulvestrant.

    Code Info

    Lot numbers: 1470 (expiry date 02-Aug-16); 1480 (expiry date 05-Aug-16), 1490 (expiry date 10-Oct-16), 1500 (expiry date 10-Oct-16), 1510 (expiry date 01-Nov-16), 1528 (expiry date 01-Nov-16) 1538 (expiry date 14-Mar-17), 1548 (expiry date 09-Mar-17), 1558 (expiry date 09-Mar-17) and 1568 (expiry date 29-Mar-17)

    Distribution

    Nationwide, Puerto Rico, and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, Venezuela.

    Quantity

    Domestic: 1620; Foreign: 7597