BEUDAMED
    FDA Recall Terminated

    Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.

    Recall: Z-1444-2015 · Initiated March 4, 2015

    Recall

    Recall Number
    Z-1444-2015
    Event Number
    70767
    Firm
    Hardy Diagnostics
    FEI Number
    2022807
    Product Code
    JSI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 4, 2015
    Posted
    April 14, 2015
    Terminated
    July 13, 2015
    Address
    1430 W Mccoy Ln, Santa Maria, CA, 93455-1005

    Description

    Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.

    Reason

    The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.

    Action

    On 03/12/2015 the firm sent recall notification letters to customers. The firm's letter informs customers of the reason for recall, and requests that they discard any remaining stock of the recalled lot. The firm continues to request that even though the customer has been informed of the necessary actions that they still take a moment to complete, sign, and fax back the enclosed form stating their compliance with the above action to the attention of their Quality Assurance Department at (805) 614-9274. The firm stated that the form is required for their records and need to document the full quantity received, used and/or discarded. For replacements or credit to please contact the Customer Service Department at (800) 266-2222 and select option 1. The firm states that replacements will be sent out at no charge to customers, or a credit will be applied to the invoice. For any additional questions the firm states to contact Technical Services at (800) 266-2222, option 2 or e-mail at [email protected].

    Distribution

    Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.

    Quantity

    840 (84 pk/10)