BEUDAMED
    FDA Enforcement Class II Terminated

    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    Recall: Z-0045-2013 · Reported October 17, 2012

    Enforcement

    Recall Number
    Z-0045-2013
    Event ID
    62968
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Immunodiagnostics Systems Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 17, 2012
    Initiation Date
    August 10, 2012
    Classification Date
    October 10, 2012
    Termination Date
    December 17, 2012
    Address
    10 Didcot Way Bolden Business Park, N/A, Boldon Tyne & Wear, N/A, N/A, United Kingdom

    Description

    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    Reason

    It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.

    Code Info

    Lot 975, EXP Sep 2012

    Distribution

    Nationwide Distribution including NY, CA, ME and CT.

    Quantity

    29