BEUDAMED
    FDA Recall Terminated

    Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.

    Recall: Z-0513-2014 · Initiated October 16, 2013

    Recall

    Recall Number
    Z-0513-2014
    Event Number
    66626
    Firm
    Microgenics Corp
    FEI Number
    3010939897
    Product Code
    LFW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 16, 2013
    Posted
    December 16, 2013
    Terminated
    February 3, 2014
    Address
    46360 Fremont Blvd, Fremont, CA, 94538-6406

    Description

    Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.

    Reason

    Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.

    Action

    Microgenics Corp., part of Thermo Fisher Scientific sent an Urgent Medical Device Correction letter dated Octobere 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard. Customers with questions were instructed to contact [email protected]. For question regarding this recall call 1-800-232-3342.

    Distribution

    Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.

    Quantity

    370 units