BEUDAMED
    FDA Recall Terminated

    Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.

    Recall: Z-0595-2007 · Initiated December 22, 2006

    Recall

    Recall Number
    Z-0595-2007
    Event Number
    37363
    Firm
    Abbott Molecular
    FEI Number
    3005248192
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2006
    Posted
    March 13, 2007
    Terminated
    April 17, 2008
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.

    Reason

    The LSI D13S319 SO/13q34 SA/CEP 12 SG probe of the two mixture DNA-Probe was contaminated with LSI ATM SG/p53 SO probe. This contamination would result in 10 FISH signals in each normal cell rather than the expected 6 FISH signals in each normal cell.

    Action

    Abbott Molecular telephoned and/or sent recall letters to the Abbott FISH accounts on 12/22/06, advising them that an unexpected signal pattern with the Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 Probe was observed, confirmed and identified as a result of contamination in a subset of vials of D13S319 /CEP 12/13q34 from lot number 79500. This contamination results in 10 FISH signals in each normal cell (4 SO, 4 SG, 2 SA) rather than the expected 6 FISH signals in each normal cell (2 SO, 2 SG, 2 SA). The customers were advised that lot 80178 was also being included in the recall, and were requested to review the information carefully and assess the risk to their patient population; discontinue and destroy any unused product immediately; complete and return the enclosed reply form; review the information with laboratory personnel; and communicate the information to health care providers served in cases where the affected product were used and reported. Abbott Molecular provided replacement product for that product destroyed, upon receipt of the reply form. Any questions were directed to Abbott Molecular Technical Service at 800-553-7042, option 2.

    Distribution

    Worldwide including USA, Austria, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, and the United Kingdom.

    Quantity

    109 probe sets