BEUDAMED
    FDA Recall Terminated

    Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized, activity 1:3000 to 1:3500); Abbott Molecular Inc; list 07J02-002, part number 32-801210. invitro diagnostic.

    Recall: Z-1147-2010 · Initiated January 22, 2010

    Recall

    Recall Number
    Z-1147-2010
    Event Number
    54190
    Firm
    Abbott Molecular
    FEI Number
    3005248192
    Product Code
    KEO
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    January 22, 2010
    Posted
    March 16, 2010
    Terminated
    January 29, 2012
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized, activity 1:3000 to 1:3500); Abbott Molecular Inc; list 07J02-002, part number 32-801210. invitro diagnostic.

    Reason

    The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.

    Action

    Abbott Molecular sent Field Correction Letter/Urgent Field Safety Notice letters dated 1/21/10 to the Paraffin Pretreatment Regent Kit customers on 1/22/10, informing them that the MSDA symbology for hazardous and corrosive material is missing from the Paraffin Pretreatment Regent Kit II and Paraffin Pretreatment Regent Kit III labels. The information is missing from the vial label, kit label and package insert. The letter listed the risk and safety statements that should be included in the package insert, and advised the customers should use the kits in accordance with the listed risk and safety statements. The accounts were instructed to review this information with laboratory personnel and retain the letter for future reference, making copies of the letter and placing them in each kit in stock. Any questions were directed to their local Abbott Molecular Representative. Abbott Molecular plans to telephone each customer to ensure that they have received the letter and have disseminated the information to their laboratory personnel.

    Distribution

    Worldwide distribution: USA, Argentina, Austria, Belarus, Belgium, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Kuwait, Lebanon, Lithuania, the Netherlands, Panama, Poland, Singapore, Slovenia, South Africa, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Vietnam.

    Quantity

    305 kits