BEUDAMED
    FDA Recall Terminated

    HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455

    Recall: Z-0078-2007 · Initiated August 21, 2006

    Recall

    Recall Number
    Z-0078-2007
    Event Number
    36309
    Firm
    Hardy Media Inc Dba Hardy Diag
    FEI Number
    2022807
    Product Code
    GMZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 21, 2006
    Posted
    October 27, 2006
    Terminated
    June 14, 2011
    Address
    1430 W Mccoy Ln, Santa Maria, CA, 93455-1005

    Description

    HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455

    Reason

    Performance failure; the product is failing to show pigment development for E. coli 0157.

    Action

    Customers were first notified by phone on 8/21/06. Then all customers are faxed and mailed a signed recall letter via first class mail. All customers will be contacted, calling every few days until all have responded and all product reconciliation is made. A second recall notice was mailed 09/25/06 to include the original lot (#06192) plus an additional lot (#06235). Customers will be instructed to dispose of all remaining inventory. Hardy Diagnostics will credit or replace their purchase.

    Distribution

    Nationwide Distribution, including the states of CA, IL, ME, NV, OK, TX, UT, WA & WY

    Quantity

    850 plates