BEUDAMED
    FDA Recall Terminated

    StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) Intended for collection and processing of capillary blood to prepare plasma/serum.

    Recall: Z-2234-2008 · Initiated June 20, 2008

    Recall

    Recall Number
    Z-2234-2008
    Event Number
    48685
    Firm
    StatSpin, Inc., dba Iris Sample Processing
    FEI Number
    1221015
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 20, 2008
    Posted
    August 23, 2008
    Terminated
    May 30, 2012
    Address
    60 Glacier Dr, Westwood, MA, 02090-1800

    Description

    StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) Intended for collection and processing of capillary blood to prepare plasma/serum.

    Reason

    EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.

    Action

    Iris Sample Processing notified customers by telephone followed by an Urgent: Product Recall letter dated 6/19/08. Users are requested to return inventory, to not use product from Lot Number 7296, and to repeat tests where the recalled tubes were used. The firm identified an additional lot : 8031 was effected and recalled the lot to two consignees.

    Distribution

    Worldwide Distribution --- USA including states of CA, CO, FL, KY, KS, GA, NC, NJ, OR, PA, and countries of Canada, Hong Kong, UK.

    Quantity

    171 vials