BEUDAMED
    FDA Enforcement Class II Terminated

    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.

    Recall: Z-1130-2015 · Reported February 25, 2015

    Enforcement

    Recall Number
    Z-1130-2015
    Event ID
    70352
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Haemonetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2015
    Initiation Date
    January 26, 2015
    Classification Date
    February 19, 2015
    Termination Date
    June 5, 2015
    Address
    400 Wood Rd, Braintree, MA, 02184-2412, United States

    Description

    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.

    Reason

    Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.

    Code Info

    Lot numbers: HMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017

    Distribution

    Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.

    Quantity

    4,143 kits