BEUDAMED
    FDA Recall Terminated

    BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C, BioTron Diagnostics Inc, Hemet California, USA . For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.

    Recall: Z-1502-2012 · Initiated February 23, 2012

    Recall

    Recall Number
    Z-1502-2012
    Event Number
    61384
    Firm
    MichClone Associates, Inc.
    FEI Number
    1831312
    Product Code
    GHM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 23, 2012
    Posted
    May 9, 2012
    Terminated
    December 13, 2012
    Address
    680 Ajax Drive, Madison Heights, MI, 48071-2414

    Description

    BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C, BioTron Diagnostics Inc, Hemet California, USA . For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.

    Reason

    Two complaints received concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. Investigation found no affect on the perf

    Action

    Michclone Associates, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify affected lots, notify sub accounts, and complete and return the response form to arrange return of unused product and replacement . Forms can be returned by FAX 248(307)-9498, mail: Michclone Associates Inc. 680 Ajax Drive, Madison Heights, MI 48118 or Email: [email protected]. Questions and concerns should be addressed to Technical Support Department at 248-307-9494.

    Distribution

    Nationwide Distribution.

    Quantity

    250