BEUDAMED
    FDA Enforcement Class II Terminated

    Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.

    Recall: Z-1725-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1725-2015
    Event ID
    71244
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    May 11, 2015
    Classification Date
    June 8, 2015
    Termination Date
    June 27, 2016
    Address
    100 Abbott Park Rd, N/A, Abbott Park, IL, 60064-3502, United States

    Description

    Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.

    Reason

    The product is leaking from the cap and crystallization was noted as present around the cap.

    Code Info

    Lot number 49059UN14, Expiration data 04-MAR-2016.

    Distribution

    Worldwide Distribution - US (nationwide), Mexico, Colombia, Brazil, Germany, Hong Kong, Belgium, Czech Republic, Finland, Hungary, Ireland, China, New Zealand, Uruguay, Puerto Rico, St. Lucia, Austria, Croatia, Denmark, France, India, Isreal, Bermuda, Curacao, Cayman Islands, Jamaica, Canada, Bangladesh, Cyprus, Estonia, Greece, Indonesia, Italy, Kazakhstan, Latvia, Macedonia, Norway, Portugal, Russia, Slovakia, Spain, Taiwan, UAE, Kenya, Lithuania, Malaysia, Philippines, Qatar, Saudi Arabia, Slovenia, Sweden, Tunisia, United Kingdom, Kuwait, Luxembourg, Netherlands, Poland, Romania, Singapore, South Africa, Switzerland, Turkey, and Vietnam.

    Quantity

    8868 units