BEUDAMED
    FDA Recall Terminated

    Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; Vysis Inc., Downers Grove, IL 60515; order number 32-190078

    Recall: Z-0416-06 · Initiated October 28, 2005

    Recall

    Recall Number
    Z-0416-06
    Event Number
    33825
    Firm
    Abbott Molecular
    FEI Number
    3005248192
    Product Code
    MAO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 28, 2005
    Posted
    January 24, 2006
    Terminated
    October 5, 2006
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018

    Description

    Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; Vysis Inc., Downers Grove, IL 60515; order number 32-190078

    Reason

    The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region.

    Action

    Abbott Molecular sent letters dated October 2005 to their direct laboratory accounts on 10/28/05 via first class certified mail. The accounts were informed of the discrepancy between the actual size and region of coverage produced by the affected lots and that described in the product literature. The accounts were instructed to assess the impact of this discrepancy on the use of the product in their laboratory and to retain a copy of the letter with any of the affected product remaining in their inventory.

    Distribution

    Nationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore

    Quantity

    749 kits