BEUDAMED
    FDA Recall Terminated

    STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Distributed in the USA by : Diagnostica Stago, Inc, Five Century Drive, Parsippany, NJ 07054, Lot 02019***.

    Recall: Z-1081-04 · Initiated December 20, 2002

    Recall

    Recall Number
    Z-1081-04
    Event Number
    29169
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    JOX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2002
    Posted
    July 20, 2004
    Terminated
    July 14, 2004
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Distributed in the USA by : Diagnostica Stago, Inc, Five Century Drive, Parsippany, NJ 07054, Lot 02019***.

    Reason

    Incorrect assay ranges on the assay value insert for Heparin Control 5.

    Action

    Manufacturer notified Diagnostica Stago, US of the problem in December 2002. Diagnostica Stago sent a letter dated 12/20/2002 along with replacement insert sheet and effectiveness check forms to all consignees.

    Distribution

    Diagnostica Stago shipped 523 kits to 133 US hospitals, laboratory, and clinics nationwide. There are 6 VA Hospitals.

    Quantity

    523