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Urgent Product Correction:
Six-Part BarCode Labels for Sarstedt Tubes

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    May 17, 2005


    Six-Part BarCode Labels for Sarstedt Tubes
    For Use with COBAS AmpliScreen System


    Roche Diagnostics Corporation, Inc.
    Indianapolis, Indiana


    Roche Diagnostics has confirmed complaints received from four customers that rolls of six-part barcode labels, Roche M/N 03261549001, Batch Nos. 028868 and 029213, may contain duplicate barcode numbers. These barcode labels are used with the COBAS AmpliScreen System to identify primary and secondary pools of donor units as well as resolution and short run samples and to identify the pool and sample ID on the A-Ring map during PCR testing.

    The problem has been isolated to the two consecutive batches of labels produced between October 2004 and February 2005, Batch Numbers 028868 and 029213. The barcode IDs associated with these batches range for D26DT to D5KLG, inclusive.

    Consignees have been asked to visually inspect barcode numbers for all pooling runs and associated A-Ring maps for the presence of duplicate barcode IDs for runs in which a sample gave a "reactive" result. Inspection should begin from the date the laboratory first began using barcode labels from batches 028868 and 029213. Once consignees have received replacement inventory, any remaining un-inspected rolls of barcode labels from batch numbers 028868 and 029213 should be returned to Roche.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.


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