BEUDAMED
    FDA Recall Terminated

    RNAgents Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use. Promega Corporation, Madison, WI. USA. Bottle Label: Phenol: Chloroform: Isoamyl Alcohol (Cat.# Z5112). Part Two of Two of Z5110. Size 100ml. For laboratory Use. A component of the RNAgents Total RNA Isolation System. The RNAgents Total RNA Isolation System provides a scalable method for RNA isolation from 6 grams of tissue or 6 x 10 (eighth power) cultured cells. The system reduces the level of chromosomal DNA, a major advantage when the downstream application of amplification and analysis of RNA transcripts is desired. Isolated RNA can be resuspended in any volume, making the system ideal for microarrays.

    Recall: Z-0483-2009 · Initiated June 4, 2008

    Recall

    Recall Number
    Z-0483-2009
    Event Number
    49586
    Firm
    Promega Corpopration
    FEI Number
    3002622561
    Product Code
    LTD
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    June 4, 2008
    Posted
    December 15, 2008
    Terminated
    June 26, 2012
    Address
    2800 Woods Hollow Rd, Madison, WI, 53711-5300

    Description

    RNAgents Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use. Promega Corporation, Madison, WI. USA. Bottle Label: Phenol: Chloroform: Isoamyl Alcohol (Cat.# Z5112). Part Two of Two of Z5110. Size 100ml. For laboratory Use. A component of the RNAgents Total RNA Isolation System. The RNAgents Total RNA Isolation System provides a scalable method for RNA isolation from 6 grams of tissue or 6 x 10 (eighth power) cultured cells. The system reduces the level of chromosomal DNA, a major advantage when the downstream application of amplification and analysis of RNA transcripts is desired. Isolated RNA can be resuspended in any volume, making the system ideal for microarrays.

    Reason

    Promega Corporation received reports of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol (Part # Z5112), a component of the RNAgents Total RNA Isolation System (Catalog # Z5110). Promega product Z5112 is a mixture of phenol, chloroform and isoamyl alcohol. If phenol contacts skin, it can cause burns and poisoning. The fumes of this product are also harmful.

    Action

    Consignees were sent a "Promega Urgent Product Alert-Risk of Injury" letter dated June 9, 2008. The letter described the product, problem and provided instructions on handling, inspection and disposition of product. In addition, E-mail notifications were sent to distributors and branch offices on May 29,2008. For questions and additional information, contact your local Promega representative or Promega Technical Service at 800-356-9526 and press "4", or e-mail at [email protected].

    Distribution

    Worldwide Distribution: USA including states of IN, ME, NE, NY, WI, PA, NC, FL, OR, UT, MI, IL, AL, OR, GA, CA, MD, TX, MA, UT, MO, OH, and LA, and countries of Canada, Mexico, Brasil, China, Japan, Germany, Singapore, Great Britain, Australia and France.

    Quantity

    836