BEUDAMED
    FDA Enforcement Class III Terminated

    AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706

    Recall: Z-0745-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0745-2020
    Event ID
    84299
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Smd Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    November 15, 2019
    Classification Date
    December 26, 2019
    Termination Date
    July 1, 2020
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895, United States

    Description

    AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706

    Reason

    The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 Unable to read barcode on reagent bottle. In some cases, the quiet zone is too short and an error in barcode reading occurs. The problem is intermittent and not all vials (6 vials are available per set) have been reported to fail. The only risk to patients or users is a delay in results. The company recommends (optional) that customers pre-screen the vials to identify affected products. Customers can contact the company for reimbursement of any affected products. The company has implemented barcode checks as a temporary solution and will replace the barcode printer on the production line for products beginning with lot B*01898.

    Code Info

    Lot Numbers: IZ01893 Exp. 2019-07-31; I801890 Exp. 2019-11-30

    Distribution

    Nationwide Foreign: Columbia, Dominic Republic, Ecuador

    Quantity

    1012 units